TY  - JOUR
AU  - Kasagić-Vujanović, Irena
AU  - Jančić-Stojanović, Biljana
PY  - 2019
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3270
AB  - This paper presents integration of Quality by Design concept in the development of hydrophilic interactions liquid chromatographic methods for analysis of amitriptyline and its impurities (A, B, C, and F). This is the first time that HILIC method for amitriptyline and its impurities is developed. Using QbD concept, it is possible to design a robust method and incorporate quality directly into its development. QbD concept in combination of Design of Experiments methodology (DoE) enables creation of well-defined design space. In this study, for method optimization a Box-Behnken design was used to test the effect of acetonitrile content, buffer concentration and pH of water phase on critical system responses such as retention factor of impurity A, resolution between impurity B and impurity C, amitriptyline peak asymmetry factor and retention time of last eluted impurity F. The defined mathematical models and Monte Carlo simulations were used to identify the design space. For robustness testing, fractional factorial design was applied. Optimal chromatographic conditions were the analytical column ZORBAX NH2 (250 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (60 mM ammonium acetate, pH adjusted to 4.5 with glacial acetic acid) (92.5:7.5 v/v); column temperature 30 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm. Finally, method was fully validated and applicability of the method in tablet analysis was confirmed.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities
VL  - 173
SP  - 86
EP  - 95
DO  - 10.1016/j.jpba.2019.05.026
ER  - 

@article{
author = "Kasagić-Vujanović, Irena and Jančić-Stojanović, Biljana",
year = "2019",
abstract = "This paper presents integration of Quality by Design concept in the development of hydrophilic interactions liquid chromatographic methods for analysis of amitriptyline and its impurities (A, B, C, and F). This is the first time that HILIC method for amitriptyline and its impurities is developed. Using QbD concept, it is possible to design a robust method and incorporate quality directly into its development. QbD concept in combination of Design of Experiments methodology (DoE) enables creation of well-defined design space. In this study, for method optimization a Box-Behnken design was used to test the effect of acetonitrile content, buffer concentration and pH of water phase on critical system responses such as retention factor of impurity A, resolution between impurity B and impurity C, amitriptyline peak asymmetry factor and retention time of last eluted impurity F. The defined mathematical models and Monte Carlo simulations were used to identify the design space. For robustness testing, fractional factorial design was applied. Optimal chromatographic conditions were the analytical column ZORBAX NH2 (250 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (60 mM ammonium acetate, pH adjusted to 4.5 with glacial acetic acid) (92.5:7.5 v/v); column temperature 30 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm. Finally, method was fully validated and applicability of the method in tablet analysis was confirmed.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities",
volume = "173",
pages = "86-95",
doi = "10.1016/j.jpba.2019.05.026"
}

Kasagić-Vujanović, I.,& Jančić-Stojanović, B.. (2019). Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 173, 86-95.
https://doi.org/10.1016/j.jpba.2019.05.026

Kasagić-Vujanović I, Jančić-Stojanović B. Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities. in Journal of Pharmaceutical and Biomedical Analysis. 2019;173:86-95.
doi:10.1016/j.jpba.2019.05.026 .

Kasagić-Vujanović, Irena, Jančić-Stojanović, Biljana, "Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities" in Journal of Pharmaceutical and Biomedical Analysis, 173 (2019):86-95,
https://doi.org/10.1016/j.jpba.2019.05.026 . .

TY  - JOUR
AU  - Stajić, Ana
AU  - Maksić, Jelena
AU  - Maksić, Đoko
AU  - Forsdahl, Guro
AU  - Medenica, Mirjana
AU  - Jančić-Stojanović, Biljana
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3080
AB  - Aim: An ultra pressure liquid chromatography (UPLC)/MS/MS method for vancomycin and teicoplanin determination in human plasma was developed in accordance with analytical quality by design (AQbD) concept and fully validated. Materials & methods: Chromatographic separation was performed on ACQUITY UPLC C-18 charge surface hybrid (CSH) column (2.1 mm x 50 mm, 1.7 mu m particle size) in gradient mode and the mobile phase consisted of 0.1% formic acid in water and pure acetonitrile. The experimental design methodology was used for the definition of optimal chromatographic and protein precipitation conditions. Results: The linearity ranges were 0.05-10 mu g ml(-1) for vancomycin and 0.5-200 mu g ml(-1) for total teicoplanin. The relative standard deviations for precision estimation were below 15% and the accuracy was within 85-115% for all quality control levels. Conclusion: The method was utilized for glycopeptide antibiotics bioanalysis.
PB  - Future Sci Ltd, London
T2  - Bioanalysis
T1  - Analytical Quality by Design-based development and validation of ultra pressure liquid chromatography/MS/MS method for glycopeptide antibiotics determination in human plasma
VL  - 10
IS  - 22
SP  - 1861
EP  - 1876
DO  - 10.4155/bio-2018-0181
ER  - 

@article{
author = "Stajić, Ana and Maksić, Jelena and Maksić, Đoko and Forsdahl, Guro and Medenica, Mirjana and Jančić-Stojanović, Biljana",
year = "2018",
abstract = "Aim: An ultra pressure liquid chromatography (UPLC)/MS/MS method for vancomycin and teicoplanin determination in human plasma was developed in accordance with analytical quality by design (AQbD) concept and fully validated. Materials & methods: Chromatographic separation was performed on ACQUITY UPLC C-18 charge surface hybrid (CSH) column (2.1 mm x 50 mm, 1.7 mu m particle size) in gradient mode and the mobile phase consisted of 0.1% formic acid in water and pure acetonitrile. The experimental design methodology was used for the definition of optimal chromatographic and protein precipitation conditions. Results: The linearity ranges were 0.05-10 mu g ml(-1) for vancomycin and 0.5-200 mu g ml(-1) for total teicoplanin. The relative standard deviations for precision estimation were below 15% and the accuracy was within 85-115% for all quality control levels. Conclusion: The method was utilized for glycopeptide antibiotics bioanalysis.",
publisher = "Future Sci Ltd, London",
journal = "Bioanalysis",
title = "Analytical Quality by Design-based development and validation of ultra pressure liquid chromatography/MS/MS method for glycopeptide antibiotics determination in human plasma",
volume = "10",
number = "22",
pages = "1861-1876",
doi = "10.4155/bio-2018-0181"
}

Stajić, A., Maksić, J., Maksić, Đ., Forsdahl, G., Medenica, M.,& Jančić-Stojanović, B.. (2018). Analytical Quality by Design-based development and validation of ultra pressure liquid chromatography/MS/MS method for glycopeptide antibiotics determination in human plasma. in Bioanalysis
Future Sci Ltd, London., 10(22), 1861-1876.
https://doi.org/10.4155/bio-2018-0181

Stajić A, Maksić J, Maksić Đ, Forsdahl G, Medenica M, Jančić-Stojanović B. Analytical Quality by Design-based development and validation of ultra pressure liquid chromatography/MS/MS method for glycopeptide antibiotics determination in human plasma. in Bioanalysis. 2018;10(22):1861-1876.
doi:10.4155/bio-2018-0181 .

Stajić, Ana, Maksić, Jelena, Maksić, Đoko, Forsdahl, Guro, Medenica, Mirjana, Jančić-Stojanović, Biljana, "Analytical Quality by Design-based development and validation of ultra pressure liquid chromatography/MS/MS method for glycopeptide antibiotics determination in human plasma" in Bioanalysis, 10, no. 22 (2018):1861-1876,
https://doi.org/10.4155/bio-2018-0181 . .

TY  - JOUR
AU  - Forsdahl, Guro
AU  - Jančić-Stojanović, Biljana
AU  - Anđelković, Marija
AU  - Dikić, Nenad
AU  - Geisendorfer, Tomas
AU  - Jeitler, Veronika
AU  - Gmeiner, Gunter
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3044
AB  - Meldonium is a drug exhibiting cardioprotective and anti-ischemic effects. Due to its potential performance-enhancing benefit in sports, meldonium was added to the World Anti-Doping Agency list of prohibited substances in 2016. Since then, a high number of adverse analytical findings reported on meldonium has questioned meldonium's detection time in urine. Hence, the objective of the current study was to characterize the pharmacokinetic urinary excretion pattern of meldonium when administered as multiple intravenous injections. Three injections of 250 mg meldonium were given over a time period of five days to six healthy volunteers and urine samples were collected for eight months after the last injection of the drug. For the quantification of meldonium in urine, a liquid chromatography-tandem mass spectrometry method was fully validated according to the World Anti-Doping Agency guidelines in terms of specificity, matrix interferences, intra- and inter-day precision, accuracy, carry-over, robustness, linearity, limit of detection, and limit of quantification. The assay was successfully applied to the pharmacokinetic study. A three-compartment model was found to best describe the pharmacokinetics of meldonium with average alpha, beta, and gamma half-lives of 1.4 h, 9.4 h, and 655 h, respectively. The detection time in urine varied between 94 and 162 days.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Urinary excretion studies of meldonium after multidose parenteral application
VL  - 161
SP  - 289
EP  - 295
DO  - 10.1016/j.jpba.2018.08.053
ER  - 

@article{
author = "Forsdahl, Guro and Jančić-Stojanović, Biljana and Anđelković, Marija and Dikić, Nenad and Geisendorfer, Tomas and Jeitler, Veronika and Gmeiner, Gunter",
year = "2018",
abstract = "Meldonium is a drug exhibiting cardioprotective and anti-ischemic effects. Due to its potential performance-enhancing benefit in sports, meldonium was added to the World Anti-Doping Agency list of prohibited substances in 2016. Since then, a high number of adverse analytical findings reported on meldonium has questioned meldonium's detection time in urine. Hence, the objective of the current study was to characterize the pharmacokinetic urinary excretion pattern of meldonium when administered as multiple intravenous injections. Three injections of 250 mg meldonium were given over a time period of five days to six healthy volunteers and urine samples were collected for eight months after the last injection of the drug. For the quantification of meldonium in urine, a liquid chromatography-tandem mass spectrometry method was fully validated according to the World Anti-Doping Agency guidelines in terms of specificity, matrix interferences, intra- and inter-day precision, accuracy, carry-over, robustness, linearity, limit of detection, and limit of quantification. The assay was successfully applied to the pharmacokinetic study. A three-compartment model was found to best describe the pharmacokinetics of meldonium with average alpha, beta, and gamma half-lives of 1.4 h, 9.4 h, and 655 h, respectively. The detection time in urine varied between 94 and 162 days.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Urinary excretion studies of meldonium after multidose parenteral application",
volume = "161",
pages = "289-295",
doi = "10.1016/j.jpba.2018.08.053"
}

Forsdahl, G., Jančić-Stojanović, B., Anđelković, M., Dikić, N., Geisendorfer, T., Jeitler, V.,& Gmeiner, G.. (2018). Urinary excretion studies of meldonium after multidose parenteral application. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 161, 289-295.
https://doi.org/10.1016/j.jpba.2018.08.053

Forsdahl G, Jančić-Stojanović B, Anđelković M, Dikić N, Geisendorfer T, Jeitler V, Gmeiner G. Urinary excretion studies of meldonium after multidose parenteral application. in Journal of Pharmaceutical and Biomedical Analysis. 2018;161:289-295.
doi:10.1016/j.jpba.2018.08.053 .

Forsdahl, Guro, Jančić-Stojanović, Biljana, Anđelković, Marija, Dikić, Nenad, Geisendorfer, Tomas, Jeitler, Veronika, Gmeiner, Gunter, "Urinary excretion studies of meldonium after multidose parenteral application" in Journal of Pharmaceutical and Biomedical Analysis, 161 (2018):289-295,
https://doi.org/10.1016/j.jpba.2018.08.053 . .

TY  - JOUR
AU  - Kasagić-Vujanović, Irena
AU  - Jančić-Stojanović, Biljana
AU  - Ivanović, Darko
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3041
AB  - Using theoretical models, retention mechanisms of amlodipine besilate and its impurities D, E, and F were tested, as well as bisoprolol fumarate and its impurities A, C, K, and L. Appropriate theoretical retention models for tested compounds were used, which enabled the determination of retention mechanisms responsible for the separation of tested compounds on three different HILIC column: silica, amino, and diol. In order to describe the effect of ratio of aqueous and organic portion of the mobile phase on the retention behavior of tested compounds, as well as the consideration of shares of partition and adsorption processes in HILIC retention mechanism in all three columns, partitioning and adsorption retention theoretical models were calculated. For this purpose, the water content was varied in the range from 4% to 29%, corresponding to the HILIC region of mobile phase composition. During the experiment, values of other factors of mobile phase were maintained at a constant level. Regression coefficients of partition and adsorption retention models and the corresponding determination coefficients were determined (R-2). Partitioning models for all tested compounds on amino column had higher R-2 values, while adsorption models for all compounds tested on silica and diol column had higher R-2 value. [GRAPHICS] .
PB  - Taylor & Francis Inc, Philadelphia
T2  - Journal of Liquid Chromatography & Related Technologies
T1  - Investigation of the retention mechanisms of amlodipine besylate, bisoprolol fumarate, and their impurities on three different HILIC columns
VL  - 41
IS  - 9
SP  - 523
EP  - 531
DO  - 10.1080/10826076.2018.1476380
ER  - 

@article{
author = "Kasagić-Vujanović, Irena and Jančić-Stojanović, Biljana and Ivanović, Darko",
year = "2018",
abstract = "Using theoretical models, retention mechanisms of amlodipine besilate and its impurities D, E, and F were tested, as well as bisoprolol fumarate and its impurities A, C, K, and L. Appropriate theoretical retention models for tested compounds were used, which enabled the determination of retention mechanisms responsible for the separation of tested compounds on three different HILIC column: silica, amino, and diol. In order to describe the effect of ratio of aqueous and organic portion of the mobile phase on the retention behavior of tested compounds, as well as the consideration of shares of partition and adsorption processes in HILIC retention mechanism in all three columns, partitioning and adsorption retention theoretical models were calculated. For this purpose, the water content was varied in the range from 4% to 29%, corresponding to the HILIC region of mobile phase composition. During the experiment, values of other factors of mobile phase were maintained at a constant level. Regression coefficients of partition and adsorption retention models and the corresponding determination coefficients were determined (R-2). Partitioning models for all tested compounds on amino column had higher R-2 values, while adsorption models for all compounds tested on silica and diol column had higher R-2 value. [GRAPHICS] .",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Journal of Liquid Chromatography & Related Technologies",
title = "Investigation of the retention mechanisms of amlodipine besylate, bisoprolol fumarate, and their impurities on three different HILIC columns",
volume = "41",
number = "9",
pages = "523-531",
doi = "10.1080/10826076.2018.1476380"
}

Kasagić-Vujanović, I., Jančić-Stojanović, B.,& Ivanović, D.. (2018). Investigation of the retention mechanisms of amlodipine besylate, bisoprolol fumarate, and their impurities on three different HILIC columns. in Journal of Liquid Chromatography & Related Technologies
Taylor & Francis Inc, Philadelphia., 41(9), 523-531.
https://doi.org/10.1080/10826076.2018.1476380

Kasagić-Vujanović I, Jančić-Stojanović B, Ivanović D. Investigation of the retention mechanisms of amlodipine besylate, bisoprolol fumarate, and their impurities on three different HILIC columns. in Journal of Liquid Chromatography & Related Technologies. 2018;41(9):523-531.
doi:10.1080/10826076.2018.1476380 .

Kasagić-Vujanović, Irena, Jančić-Stojanović, Biljana, Ivanović, Darko, "Investigation of the retention mechanisms of amlodipine besylate, bisoprolol fumarate, and their impurities on three different HILIC columns" in Journal of Liquid Chromatography & Related Technologies, 41, no. 9 (2018):523-531,
https://doi.org/10.1080/10826076.2018.1476380 . .

TY  - JOUR
AU  - Terzić, Jelena
AU  - Popović, Igor
AU  - Tumpa, Anja
AU  - Stajić, Ana
AU  - Jančić-Stojanović, Biljana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3022
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method (vol 125, pg 385, 2016)
VL  - 138
SP  - 386
EP  - 386
DO  - 10.1016/j.jpba.2017.02.016
ER  - 

@article{
author = "Terzić, Jelena and Popović, Igor and Tumpa, Anja and Stajić, Ana and Jančić-Stojanović, Biljana",
year = "2017",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method (vol 125, pg 385, 2016)",
volume = "138",
pages = "386-386",
doi = "10.1016/j.jpba.2017.02.016"
}

Terzić, J., Popović, I., Tumpa, A., Stajić, A.,& Jančić-Stojanović, B.. (2017). Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method (vol 125, pg 385, 2016). in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 138, 386-386.
https://doi.org/10.1016/j.jpba.2017.02.016

Terzić J, Popović I, Tumpa A, Stajić A, Jančić-Stojanović B. Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method (vol 125, pg 385, 2016). in Journal of Pharmaceutical and Biomedical Analysis. 2017;138:386-386.
doi:10.1016/j.jpba.2017.02.016 .

Terzić, Jelena, Popović, Igor, Tumpa, Anja, Stajić, Ana, Jančić-Stojanović, Biljana, "Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method (vol 125, pg 385, 2016)" in Journal of Pharmaceutical and Biomedical Analysis, 138 (2017):386-386,
https://doi.org/10.1016/j.jpba.2017.02.016 . .

TY  - JOUR
AU  - Dobričić, Vladimir
AU  - Vukadinović, Dragana
AU  - Jančić-Stojanović, Biljana
AU  - Vladimirov, Sote
AU  - Čudina, Olivera
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3002
AB  - Analytical quality by design (AQbD)-oriented liquid chromatographic method development for determination of telmisartan and its impurities A, C, and 1 is determination is presented. Step-by-step process was conducted in order to define reliable design space. At the beginning, critical process parameters with the highest influence on method performance were defined: acetonitrile content in the first (ACN 1) and second (ACN 2) gradient step and time (t (2)) the second gradient step. These factors were varied according to Box-Behnken plan of experiments and their influence on retention times of impurities A and C, S value between telmisartan and impurity 1 and peak capacity were followed. In this way, the relationship between the critical process parameters and critical quality attributes was established. The obtained mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing, and the method was validated to verify the adequacy of selected optimal conditions. Finally, all validation parameters were tested, and adequacy of the method was confirmed. Applicability as a routine method was confirmed by analysis of commercially available tablets.
PB  - Springer Heidelberg, Heidelberg
T2  - Chromatographia
T1  - AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities
VL  - 80
IS  - 8
SP  - 1199
EP  - 1209
DO  - 10.1007/s10337-017-3330-2
ER  - 

@article{
author = "Dobričić, Vladimir and Vukadinović, Dragana and Jančić-Stojanović, Biljana and Vladimirov, Sote and Čudina, Olivera",
year = "2017",
abstract = "Analytical quality by design (AQbD)-oriented liquid chromatographic method development for determination of telmisartan and its impurities A, C, and 1 is determination is presented. Step-by-step process was conducted in order to define reliable design space. At the beginning, critical process parameters with the highest influence on method performance were defined: acetonitrile content in the first (ACN 1) and second (ACN 2) gradient step and time (t (2)) the second gradient step. These factors were varied according to Box-Behnken plan of experiments and their influence on retention times of impurities A and C, S value between telmisartan and impurity 1 and peak capacity were followed. In this way, the relationship between the critical process parameters and critical quality attributes was established. The obtained mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing, and the method was validated to verify the adequacy of selected optimal conditions. Finally, all validation parameters were tested, and adequacy of the method was confirmed. Applicability as a routine method was confirmed by analysis of commercially available tablets.",
publisher = "Springer Heidelberg, Heidelberg",
journal = "Chromatographia",
title = "AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities",
volume = "80",
number = "8",
pages = "1199-1209",
doi = "10.1007/s10337-017-3330-2"
}

Dobričić, V., Vukadinović, D., Jančić-Stojanović, B., Vladimirov, S.,& Čudina, O.. (2017). AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities. in Chromatographia
Springer Heidelberg, Heidelberg., 80(8), 1199-1209.
https://doi.org/10.1007/s10337-017-3330-2

Dobričić V, Vukadinović D, Jančić-Stojanović B, Vladimirov S, Čudina O. AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities. in Chromatographia. 2017;80(8):1199-1209.
doi:10.1007/s10337-017-3330-2 .

Dobričić, Vladimir, Vukadinović, Dragana, Jančić-Stojanović, Biljana, Vladimirov, Sote, Čudina, Olivera, "AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities" in Chromatographia, 80, no. 8 (2017):1199-1209,
https://doi.org/10.1007/s10337-017-3330-2 . .

TY  - CONF
AU  - Kasagić-Vujanović, Irena
AU  - Jančić-Stojanović, Biljana
AU  - Ivanović, Darko
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2962
AB  - Stability studies of drugs by stress study is a very important process which is done by treating the study drug with different stress agents, with the aim to define the critical factors affecting the stability of the drug, to accurately define the storage conditions of the drug, as well as to identify the resulting degradation products. In this paper, stress studies of bisoprolol fumarate were performed, in order to examine what are the stress agents that affect its stability. For the analysis previously optimized and validated HILIC method was used It was demonstrated that oxidative stress agent has the largest effect on the degradation of bisoprolol fumarate, and then the acid and base stress agent successively. Water, as a neutral medium, and light had no significant effect on the stability of bisoprolol fumarate. During degradation under acid conditions impurity A was formed and it was confirmed with UPLC/MS/MS method. In order to more clearly define the processes of degradation, kinetic studies of degradation of bisoprolol fumarate have been carried out, in order to determine the order of the reaction rate of degradation and degradation half-time, which provided clearer definition of the mechanism of degradation.
PB  - Springer-Verlag Singapore Pte Ltd, Singapore
C3  - Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017
T1  - Monitoring of bisoprolol fumarate stability under different stress conditions
VL  - 62
SP  - 415
EP  - 424
DO  - 10.1007/978-981-10-4166-2_64
ER  - 

@conference{
author = "Kasagić-Vujanović, Irena and Jančić-Stojanović, Biljana and Ivanović, Darko",
year = "2017",
abstract = "Stability studies of drugs by stress study is a very important process which is done by treating the study drug with different stress agents, with the aim to define the critical factors affecting the stability of the drug, to accurately define the storage conditions of the drug, as well as to identify the resulting degradation products. In this paper, stress studies of bisoprolol fumarate were performed, in order to examine what are the stress agents that affect its stability. For the analysis previously optimized and validated HILIC method was used It was demonstrated that oxidative stress agent has the largest effect on the degradation of bisoprolol fumarate, and then the acid and base stress agent successively. Water, as a neutral medium, and light had no significant effect on the stability of bisoprolol fumarate. During degradation under acid conditions impurity A was formed and it was confirmed with UPLC/MS/MS method. In order to more clearly define the processes of degradation, kinetic studies of degradation of bisoprolol fumarate have been carried out, in order to determine the order of the reaction rate of degradation and degradation half-time, which provided clearer definition of the mechanism of degradation.",
publisher = "Springer-Verlag Singapore Pte Ltd, Singapore",
journal = "Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017",
title = "Monitoring of bisoprolol fumarate stability under different stress conditions",
volume = "62",
pages = "415-424",
doi = "10.1007/978-981-10-4166-2_64"
}

Kasagić-Vujanović, I., Jančić-Stojanović, B.,& Ivanović, D.. (2017). Monitoring of bisoprolol fumarate stability under different stress conditions. in Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017
Springer-Verlag Singapore Pte Ltd, Singapore., 62, 415-424.
https://doi.org/10.1007/978-981-10-4166-2_64

Kasagić-Vujanović I, Jančić-Stojanović B, Ivanović D. Monitoring of bisoprolol fumarate stability under different stress conditions. in Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017. 2017;62:415-424.
doi:10.1007/978-981-10-4166-2_64 .

Kasagić-Vujanović, Irena, Jančić-Stojanović, Biljana, Ivanović, Darko, "Monitoring of bisoprolol fumarate stability under different stress conditions" in Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017, 62 (2017):415-424,
https://doi.org/10.1007/978-981-10-4166-2_64 . .

TY  - JOUR
AU  - Tumpa, Anja
AU  - Stajić, Ana
AU  - Jančić-Stojanović, Biljana
AU  - Medenica, Mirjana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2958
AB  - This paper deals with the development of hydrophilic interaction liquid chromatography (HILIC) method with gradient elution, in accordance with Analytical Quality by Design (AQbD) methodology, for the first time. The method is developed for olanzapine and its seven related substances. Following step by step AQbD methodology, firstly as critical process parameters (CPPs) temperature, starting content of aqueous phase and duration of linear gradient are recognized, and as critical quality attributes (CQAs) separation criterion S of critical pairs of substances are investigated. Rechtschaffen design is used for the creation of models that describe the dependence between CPPs and CQAs. The design space that is obtained at the end is used for choosing the optimal conditions (set point). The method is fully validated at the end to verify the adequacy of the chosen optimal conditions and applied to real samples.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine
VL  - 134
SP  - 18
EP  - 26
DO  - 10.1016/j.jpba.2016.11.010
ER  - 

@article{
author = "Tumpa, Anja and Stajić, Ana and Jančić-Stojanović, Biljana and Medenica, Mirjana",
year = "2017",
abstract = "This paper deals with the development of hydrophilic interaction liquid chromatography (HILIC) method with gradient elution, in accordance with Analytical Quality by Design (AQbD) methodology, for the first time. The method is developed for olanzapine and its seven related substances. Following step by step AQbD methodology, firstly as critical process parameters (CPPs) temperature, starting content of aqueous phase and duration of linear gradient are recognized, and as critical quality attributes (CQAs) separation criterion S of critical pairs of substances are investigated. Rechtschaffen design is used for the creation of models that describe the dependence between CPPs and CQAs. The design space that is obtained at the end is used for choosing the optimal conditions (set point). The method is fully validated at the end to verify the adequacy of the chosen optimal conditions and applied to real samples.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine",
volume = "134",
pages = "18-26",
doi = "10.1016/j.jpba.2016.11.010"
}

Tumpa, A., Stajić, A., Jančić-Stojanović, B.,& Medenica, M.. (2017). Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 134, 18-26.
https://doi.org/10.1016/j.jpba.2016.11.010

Tumpa A, Stajić A, Jančić-Stojanović B, Medenica M. Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine. in Journal of Pharmaceutical and Biomedical Analysis. 2017;134:18-26.
doi:10.1016/j.jpba.2016.11.010 .

Tumpa, Anja, Stajić, Ana, Jančić-Stojanović, Biljana, Medenica, Mirjana, "Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine" in Journal of Pharmaceutical and Biomedical Analysis, 134 (2017):18-26,
https://doi.org/10.1016/j.jpba.2016.11.010 . .

TY  - JOUR
AU  - Milić, Jela
AU  - Radojković, Branko
AU  - Jančić-Stojanović, Biljana
AU  - Drašković, Jasmina
AU  - Mirašević, Slavica
AU  - Čalija, Bojan
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2943
AB  - In this paper, a study exploring the stability of omeprazole in pediatric suspensions is presented. In order to determine the most suitable suspension, three different formulations were prepared and stored under refrigerated conditions and at room temperature for 30 days. Contents of omeprazole and preservatives were determined by liquid chromatographic method. Obtained results demonstrate that the vehicle consisting of: xanthan gum 0.3%, sodium bicarbonate 8%, Compound hydroxybenzoate solution APF 1% and purified water to 100% could have a significant potential in the development of a suitable omeprazole oral liquid for pediatric use. Namely, the content of omeprazole in the suspension prepared with this vehicle remained within acceptable range during the 30-day period, when stored refrigerated (2-8°C).
AB  - U ovom radu predstavljeno je ispitivanje stabilnosti omeprazola u suspenzijama za pedijatrijsku primenu, koje su izrađene iz komercijalno dostupnih kapsula omeprazola u uslovima apoteke. U cilju utvrđivanja najpogodnijeg vehikuluma za magistralnu izradu suspenzija omeprazola, pripremljene su tri formulacije, koje su potom 30 dana čuvane u frižideru i na sobnoj temperaturi. Sadržaj omeprazola i konzervansa u suspenzijama je određivan primenom tečne hromatografije. Dobijeni rezultati ukazuju da vehikulum koji se sastoji iz ksantan gume 0,3%, natrijum-bikarbonata 8%, rastvora parabena 1% (Compound hydroxybenzoate solution APF) i prečišćene vode do 100% ima značajan potencijal za razvoj pogodnog tečnog oblika omeprazola za peroralnu primenu u pedijatrijskoj populaciji. Naime, sadržaj omeprazola u suspenziji pripremljenoj primenom ovog vehikuluma je ostao u okviru prihvatljivih granica tokom perioda od 30 dana, kada je suspenzija čuvana u frižideru (2-8°C).
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules
T1  - Ispitivanje stabilnosti oralnih suspenzija omeprazola za pedijatrijsku primenu magistralno izrađenih iz omeprazol kapsula
VL  - 67
IS  - 1
SP  - 14
EP  - 25
DO  - 10.5937/arhfarm1701014M
ER  - 

@article{
author = "Milić, Jela and Radojković, Branko and Jančić-Stojanović, Biljana and Drašković, Jasmina and Mirašević, Slavica and Čalija, Bojan",
year = "2017",
abstract = "In this paper, a study exploring the stability of omeprazole in pediatric suspensions is presented. In order to determine the most suitable suspension, three different formulations were prepared and stored under refrigerated conditions and at room temperature for 30 days. Contents of omeprazole and preservatives were determined by liquid chromatographic method. Obtained results demonstrate that the vehicle consisting of: xanthan gum 0.3%, sodium bicarbonate 8%, Compound hydroxybenzoate solution APF 1% and purified water to 100% could have a significant potential in the development of a suitable omeprazole oral liquid for pediatric use. Namely, the content of omeprazole in the suspension prepared with this vehicle remained within acceptable range during the 30-day period, when stored refrigerated (2-8°C)., U ovom radu predstavljeno je ispitivanje stabilnosti omeprazola u suspenzijama za pedijatrijsku primenu, koje su izrađene iz komercijalno dostupnih kapsula omeprazola u uslovima apoteke. U cilju utvrđivanja najpogodnijeg vehikuluma za magistralnu izradu suspenzija omeprazola, pripremljene su tri formulacije, koje su potom 30 dana čuvane u frižideru i na sobnoj temperaturi. Sadržaj omeprazola i konzervansa u suspenzijama je određivan primenom tečne hromatografije. Dobijeni rezultati ukazuju da vehikulum koji se sastoji iz ksantan gume 0,3%, natrijum-bikarbonata 8%, rastvora parabena 1% (Compound hydroxybenzoate solution APF) i prečišćene vode do 100% ima značajan potencijal za razvoj pogodnog tečnog oblika omeprazola za peroralnu primenu u pedijatrijskoj populaciji. Naime, sadržaj omeprazola u suspenziji pripremljenoj primenom ovog vehikuluma je ostao u okviru prihvatljivih granica tokom perioda od 30 dana, kada je suspenzija čuvana u frižideru (2-8°C).",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules, Ispitivanje stabilnosti oralnih suspenzija omeprazola za pedijatrijsku primenu magistralno izrađenih iz omeprazol kapsula",
volume = "67",
number = "1",
pages = "14-25",
doi = "10.5937/arhfarm1701014M"
}

Milić, J., Radojković, B., Jančić-Stojanović, B., Drašković, J., Mirašević, S.,& Čalija, B.. (2017). Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 67(1), 14-25.
https://doi.org/10.5937/arhfarm1701014M

Milić J, Radojković B, Jančić-Stojanović B, Drašković J, Mirašević S, Čalija B. Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules. in Arhiv za farmaciju. 2017;67(1):14-25.
doi:10.5937/arhfarm1701014M .

Milić, Jela, Radojković, Branko, Jančić-Stojanović, Biljana, Drašković, Jasmina, Mirašević, Slavica, Čalija, Bojan, "Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules" in Arhiv za farmaciju, 67, no. 1 (2017):14-25,
https://doi.org/10.5937/arhfarm1701014M . .

TY  - JOUR
AU  - Stajić, Ana
AU  - Jančić-Stojanović, Biljana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2935
AB  - Background. Teicoplanin and vancomycin are glycopeptide antibiotics currently in use for treatment of multidrug-resistant bacterial infections. Scope and Approach. Severe undesirable effects, such as ototoxicity, nephrotoxicity and neutropenia have been reported for vancomycin and teicoplanin, which necessitates monitoring the concentration of these two drugs in different biological samples. In order to obtain precise and accurate results, sensitive, reliable and fast methods are necessary. The main aim of this mini review is to give a clear and concise overview of the recently developed, validated, novel and improved methods for glycopeptide antibiotic analyses in various biological matrices. Also, the variability of the matrices requires optimal and effective sample preparation procedures to be developed, and so these are discussed. Key Findings and Conclusions. Different liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods have been described for quantitative determination of glycopeptide antibiotics in various biological matrices. It was shown that protein precipitation was a convenient method for sample preparation despite the high number of novel sample preparation methods.
AB  - Uvod. Teikoplanin i vankomicin su antibiotici glikopeptidne strukture koji se trenutno koriste u terapiji multirezistentnih bakterijskih infekcija. Cilj i pristup. Ozbiljni neželjeni efekti vankomicina i teikoplanina kao što su ototoksičnost, nefrotoksičnost i neutropenija zahtevaju njihovo praćenje u različitim tipovima biološkog materijala. Osetljiva, pouzdana i brza metoda potrebna je u cilju dobijanja tačnih i preciznih podataka o koncentraciji pomenutih jedinjenja. Cilj ovog pregleda je da da jasan i kratak prikaz o razvijenim i validiranim novim, ili unapređenim metodama za analizu glikopeptidnih antibiotika u različitim biološkim matriksima. Takođe, u radu su opisane i metode pripreme uzorka upravo zbog raznovrsnosti biološkog materijala. Ključni nalazi i zaključak. Opisane su raznovrsne LC-MS/MS metode za određivanje glikopeptidnih antibiotika u biološkom materijalu. Primećeno je da je precipitacija proteina pogodna metoda pripreme uzorka bez obzira na broj novijih metoda pripreme koje se koriste.
PB  - Univerzitet u Beogradu - Fakultet veterinarske medicine, Beograd
T2  - Veterinarski glasnik
T1  - Overview of the analytical methods for vancomycin and/or teicoplanin determination in biological matrices
T1  - Pregled analitičkih metoda za određivanje vankomicina i teikoplanina u biološkom materijalu
VL  - 71
IS  - 2
SP  - 87
EP  - 97
DO  - 10.2298/VETGL1702087S
ER  - 

@article{
author = "Stajić, Ana and Jančić-Stojanović, Biljana",
year = "2017",
abstract = "Background. Teicoplanin and vancomycin are glycopeptide antibiotics currently in use for treatment of multidrug-resistant bacterial infections. Scope and Approach. Severe undesirable effects, such as ototoxicity, nephrotoxicity and neutropenia have been reported for vancomycin and teicoplanin, which necessitates monitoring the concentration of these two drugs in different biological samples. In order to obtain precise and accurate results, sensitive, reliable and fast methods are necessary. The main aim of this mini review is to give a clear and concise overview of the recently developed, validated, novel and improved methods for glycopeptide antibiotic analyses in various biological matrices. Also, the variability of the matrices requires optimal and effective sample preparation procedures to be developed, and so these are discussed. Key Findings and Conclusions. Different liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods have been described for quantitative determination of glycopeptide antibiotics in various biological matrices. It was shown that protein precipitation was a convenient method for sample preparation despite the high number of novel sample preparation methods., Uvod. Teikoplanin i vankomicin su antibiotici glikopeptidne strukture koji se trenutno koriste u terapiji multirezistentnih bakterijskih infekcija. Cilj i pristup. Ozbiljni neželjeni efekti vankomicina i teikoplanina kao što su ototoksičnost, nefrotoksičnost i neutropenija zahtevaju njihovo praćenje u različitim tipovima biološkog materijala. Osetljiva, pouzdana i brza metoda potrebna je u cilju dobijanja tačnih i preciznih podataka o koncentraciji pomenutih jedinjenja. Cilj ovog pregleda je da da jasan i kratak prikaz o razvijenim i validiranim novim, ili unapređenim metodama za analizu glikopeptidnih antibiotika u različitim biološkim matriksima. Takođe, u radu su opisane i metode pripreme uzorka upravo zbog raznovrsnosti biološkog materijala. Ključni nalazi i zaključak. Opisane su raznovrsne LC-MS/MS metode za određivanje glikopeptidnih antibiotika u biološkom materijalu. Primećeno je da je precipitacija proteina pogodna metoda pripreme uzorka bez obzira na broj novijih metoda pripreme koje se koriste.",
publisher = "Univerzitet u Beogradu - Fakultet veterinarske medicine, Beograd",
journal = "Veterinarski glasnik",
title = "Overview of the analytical methods for vancomycin and/or teicoplanin determination in biological matrices, Pregled analitičkih metoda za određivanje vankomicina i teikoplanina u biološkom materijalu",
volume = "71",
number = "2",
pages = "87-97",
doi = "10.2298/VETGL1702087S"
}

Stajić, A.,& Jančić-Stojanović, B.. (2017). Overview of the analytical methods for vancomycin and/or teicoplanin determination in biological matrices. in Veterinarski glasnik
Univerzitet u Beogradu - Fakultet veterinarske medicine, Beograd., 71(2), 87-97.
https://doi.org/10.2298/VETGL1702087S

Stajić A, Jančić-Stojanović B. Overview of the analytical methods for vancomycin and/or teicoplanin determination in biological matrices. in Veterinarski glasnik. 2017;71(2):87-97.
doi:10.2298/VETGL1702087S .

Stajić, Ana, Jančić-Stojanović, Biljana, "Overview of the analytical methods for vancomycin and/or teicoplanin determination in biological matrices" in Veterinarski glasnik, 71, no. 2 (2017):87-97,
https://doi.org/10.2298/VETGL1702087S . .

TY  - JOUR
AU  - Stajić, Ana
AU  - Anđelković, Marija
AU  - Dikić, Nenad
AU  - Rasić, J.
AU  - Vukašinović-Vesić, Milica
AU  - Ivanović, D.
AU  - Jančić-Stojanović, Biljana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2869
AB  - From 1st January 2017 higenamine was added on the WADA (World Anti-doping Agency) Prohibited list under S3 group beta-2 agonists as at all times banned substance for the athletes. The main origine of higenamine (or norcoclaurine) are different plants including Nandina domestica, Aconitum carmichaelii, Asarum heterotropioides, Galium divaricatum, Annona squamosa, Nelumbo nucifera etc. Higenamine main use is related to weight loss and it could be found (un)labeled in different dietary supplements. The objective of this study was development of sensitive and reliable UHPLC/MS/MS method for determination of higenamine in various dietary supplement samples. In order to obtain high method sensitivity, hydrophilic interaction liquid chromatography (HILIC) mode was applied. Separation was carried out on UHPLC Acquity BEH HILIC analytical column (2.1 mm x 100 mm, 1.7 mu m particle size). Mobile phase consisted of 0.1% formic acid in water and acetonitrile, respectively, was mixed in ratio of 30:70, v/v. Flow rate was set at 0.2 mL min(-1). Quercetin was used as an internal standard. ESI (+) source ionization mode using multi reaction monitoring (MRM) mode was utilized and three ion transitions of higenamine were followed 272.08 -> 107.01, 272.08 -> 161.07 and 272.08 -> 77.08. Developed method was fully validated and applied for identification and quantification of higenamine in different dietary supplements. According to the results, the most of investigated supplements were free of higenamine, and on the other hand, presence of higenamine was confirmed in some samples while it was not declared on the label.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Determination of higenamine in dietary supplements by UHPLC/MS/MS method
VL  - 146
SP  - 48
EP  - 52
DO  - 10.1016/j.jpba.2017.08.017
ER  - 

@article{
author = "Stajić, Ana and Anđelković, Marija and Dikić, Nenad and Rasić, J. and Vukašinović-Vesić, Milica and Ivanović, D. and Jančić-Stojanović, Biljana",
year = "2017",
abstract = "From 1st January 2017 higenamine was added on the WADA (World Anti-doping Agency) Prohibited list under S3 group beta-2 agonists as at all times banned substance for the athletes. The main origine of higenamine (or norcoclaurine) are different plants including Nandina domestica, Aconitum carmichaelii, Asarum heterotropioides, Galium divaricatum, Annona squamosa, Nelumbo nucifera etc. Higenamine main use is related to weight loss and it could be found (un)labeled in different dietary supplements. The objective of this study was development of sensitive and reliable UHPLC/MS/MS method for determination of higenamine in various dietary supplement samples. In order to obtain high method sensitivity, hydrophilic interaction liquid chromatography (HILIC) mode was applied. Separation was carried out on UHPLC Acquity BEH HILIC analytical column (2.1 mm x 100 mm, 1.7 mu m particle size). Mobile phase consisted of 0.1% formic acid in water and acetonitrile, respectively, was mixed in ratio of 30:70, v/v. Flow rate was set at 0.2 mL min(-1). Quercetin was used as an internal standard. ESI (+) source ionization mode using multi reaction monitoring (MRM) mode was utilized and three ion transitions of higenamine were followed 272.08 -> 107.01, 272.08 -> 161.07 and 272.08 -> 77.08. Developed method was fully validated and applied for identification and quantification of higenamine in different dietary supplements. According to the results, the most of investigated supplements were free of higenamine, and on the other hand, presence of higenamine was confirmed in some samples while it was not declared on the label.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Determination of higenamine in dietary supplements by UHPLC/MS/MS method",
volume = "146",
pages = "48-52",
doi = "10.1016/j.jpba.2017.08.017"
}

Stajić, A., Anđelković, M., Dikić, N., Rasić, J., Vukašinović-Vesić, M., Ivanović, D.,& Jančić-Stojanović, B.. (2017). Determination of higenamine in dietary supplements by UHPLC/MS/MS method. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 146, 48-52.
https://doi.org/10.1016/j.jpba.2017.08.017

Stajić A, Anđelković M, Dikić N, Rasić J, Vukašinović-Vesić M, Ivanović D, Jančić-Stojanović B. Determination of higenamine in dietary supplements by UHPLC/MS/MS method. in Journal of Pharmaceutical and Biomedical Analysis. 2017;146:48-52.
doi:10.1016/j.jpba.2017.08.017 .

Stajić, Ana, Anđelković, Marija, Dikić, Nenad, Rasić, J., Vukašinović-Vesić, Milica, Ivanović, D., Jančić-Stojanović, Biljana, "Determination of higenamine in dietary supplements by UHPLC/MS/MS method" in Journal of Pharmaceutical and Biomedical Analysis, 146 (2017):48-52,
https://doi.org/10.1016/j.jpba.2017.08.017 . .

TY  - JOUR
AU  - Maksić, Jelena
AU  - Stajić, Ana
AU  - Knežević, Miroslav
AU  - Dacić-Krnjaja, Bojana
AU  - Jančić-Stojanović, Biljana
AU  - Medenica, Mirjana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2860
AB  - Aim: The objective of the study was development of hydrophilic interaction liquid chromatography-ESI/MS/MS method for the determination of olopatadine in tear matrix. Materials & methods: Separation was performed on Acquity BEH amide column (2.1 x 100 mm, 1.7 mu m). The mobile phase was consisted of 0.1% formic acid in water and acetonitrile. Mianserin hydrochloride was implemented as an internal standard. The artificial tear fluid was used as matrix. The tear samples were collected using Schirmer test strips. For the optimization of ultra pressure liquid chromatography conditions, Box-Benhken design was utilized. Results: The optimal values of the ion source and collision cell parameters were found. Quantification was performed in multiple reaction monitoring mode. The optimized method was fully validated. Conclusion: The proposed method was utilized for monitoring of olopatadine in human tear.
PB  - Future Sci Ltd, London
T2  - Bioanalysis
T1  - Determination of olopatadine in human tears by hydrophilic interaction liquid chromatography-MS/MS method
VL  - 9
IS  - 24
SP  - 1943
EP  - 1954
DO  - 10.4155/bio-2017-0172
ER  - 

@article{
author = "Maksić, Jelena and Stajić, Ana and Knežević, Miroslav and Dacić-Krnjaja, Bojana and Jančić-Stojanović, Biljana and Medenica, Mirjana",
year = "2017",
abstract = "Aim: The objective of the study was development of hydrophilic interaction liquid chromatography-ESI/MS/MS method for the determination of olopatadine in tear matrix. Materials & methods: Separation was performed on Acquity BEH amide column (2.1 x 100 mm, 1.7 mu m). The mobile phase was consisted of 0.1% formic acid in water and acetonitrile. Mianserin hydrochloride was implemented as an internal standard. The artificial tear fluid was used as matrix. The tear samples were collected using Schirmer test strips. For the optimization of ultra pressure liquid chromatography conditions, Box-Benhken design was utilized. Results: The optimal values of the ion source and collision cell parameters were found. Quantification was performed in multiple reaction monitoring mode. The optimized method was fully validated. Conclusion: The proposed method was utilized for monitoring of olopatadine in human tear.",
publisher = "Future Sci Ltd, London",
journal = "Bioanalysis",
title = "Determination of olopatadine in human tears by hydrophilic interaction liquid chromatography-MS/MS method",
volume = "9",
number = "24",
pages = "1943-1954",
doi = "10.4155/bio-2017-0172"
}

Maksić, J., Stajić, A., Knežević, M., Dacić-Krnjaja, B., Jančić-Stojanović, B.,& Medenica, M.. (2017). Determination of olopatadine in human tears by hydrophilic interaction liquid chromatography-MS/MS method. in Bioanalysis
Future Sci Ltd, London., 9(24), 1943-1954.
https://doi.org/10.4155/bio-2017-0172

Maksić J, Stajić A, Knežević M, Dacić-Krnjaja B, Jančić-Stojanović B, Medenica M. Determination of olopatadine in human tears by hydrophilic interaction liquid chromatography-MS/MS method. in Bioanalysis. 2017;9(24):1943-1954.
doi:10.4155/bio-2017-0172 .

Maksić, Jelena, Stajić, Ana, Knežević, Miroslav, Dacić-Krnjaja, Bojana, Jančić-Stojanović, Biljana, Medenica, Mirjana, "Determination of olopatadine in human tears by hydrophilic interaction liquid chromatography-MS/MS method" in Bioanalysis, 9, no. 24 (2017):1943-1954,
https://doi.org/10.4155/bio-2017-0172 . .

TY  - JOUR
AU  - Tumpa, Anja
AU  - Misković, Stefan
AU  - Stanimirović, Zorica
AU  - Jančić-Stojanović, Biljana
AU  - Medenica, Mirjana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2792
AB  - When it is taken into account that hydrophilic interaction liquid chromatography (HILIC) as an analytical method is relatively young compared with the other techniques, retention modeling could still bring scientifically valuable data to the field. Therefore, in this paper, olanzapine and its 8 impurities were selected as a test mixture, considering that they have never been analyzed in HILIC before. Their investigation on 4 different HILIC columns (bare silica, cyanopropyl, diol and zwitterionic) has been performed. The mixture of 9 structurally similar substances allows the examination of complex HILIC retention behavior depending on the chemical properties of the analytes, as well as of the stationary phase. To describe the nature of the relationship between the retention and the stronger eluent content in the mobile phase, we fitted experimentally obtained data to several theoretical (localized adsorption, nonlocalized partition, quadratic, and mixed) models. Results show that the best fit is the quadratic model with the highest R-2 and cross-validated coefficient of determination (Q(2)) values, but its usage has some drawbacks. With the aim to improve the possibility to predict retention behavior in HILIC, a new empirical model was proposed. For that purpose, a spline interpolation technique was performed, by dividing the experimental range into several subdivisions. This type of interpolation was performed for the first time in the chromatographic field. The estimation of the polynomial equations was performed using Q(2) values. Obtained Q(2) values pointed out the goodness of fit of the model, as well as its good predictive capabilities. In the end, the prediction capabilities were experimentally verified, under randomly chosen conditions from the experimental range. The errors in prediction were all under 10%, which is satisfying for HILIC. In this paper, retention behavior of olanzapine and its 8 impurities was investigated on four HILIC columns (bare silica, cyanopropyl, diol, and zwitterionic). Experimentally obtained data were fitted to several theoretical (localized adsorption, nonlocalized partition, quadratic, and mixed) models. Furthermore, a new empirical model (spline interpolation) was proposed. This type of interpolation was performed for the first time in the chromatography. Obtained Q(2) values pointed out the goodness of fit of the model, as well as its good predictive capabilities.
PB  - Wiley, Hoboken
T2  - Journal of Chemometrics
T1  - Modeling of HILIC retention behavior with theoretical models and new spline interpolation technique
VL  - 31
IS  - 9
DO  - 10.1002/cem.2910
ER  - 

@article{
author = "Tumpa, Anja and Misković, Stefan and Stanimirović, Zorica and Jančić-Stojanović, Biljana and Medenica, Mirjana",
year = "2017",
abstract = "When it is taken into account that hydrophilic interaction liquid chromatography (HILIC) as an analytical method is relatively young compared with the other techniques, retention modeling could still bring scientifically valuable data to the field. Therefore, in this paper, olanzapine and its 8 impurities were selected as a test mixture, considering that they have never been analyzed in HILIC before. Their investigation on 4 different HILIC columns (bare silica, cyanopropyl, diol and zwitterionic) has been performed. The mixture of 9 structurally similar substances allows the examination of complex HILIC retention behavior depending on the chemical properties of the analytes, as well as of the stationary phase. To describe the nature of the relationship between the retention and the stronger eluent content in the mobile phase, we fitted experimentally obtained data to several theoretical (localized adsorption, nonlocalized partition, quadratic, and mixed) models. Results show that the best fit is the quadratic model with the highest R-2 and cross-validated coefficient of determination (Q(2)) values, but its usage has some drawbacks. With the aim to improve the possibility to predict retention behavior in HILIC, a new empirical model was proposed. For that purpose, a spline interpolation technique was performed, by dividing the experimental range into several subdivisions. This type of interpolation was performed for the first time in the chromatographic field. The estimation of the polynomial equations was performed using Q(2) values. Obtained Q(2) values pointed out the goodness of fit of the model, as well as its good predictive capabilities. In the end, the prediction capabilities were experimentally verified, under randomly chosen conditions from the experimental range. The errors in prediction were all under 10%, which is satisfying for HILIC. In this paper, retention behavior of olanzapine and its 8 impurities was investigated on four HILIC columns (bare silica, cyanopropyl, diol, and zwitterionic). Experimentally obtained data were fitted to several theoretical (localized adsorption, nonlocalized partition, quadratic, and mixed) models. Furthermore, a new empirical model (spline interpolation) was proposed. This type of interpolation was performed for the first time in the chromatography. Obtained Q(2) values pointed out the goodness of fit of the model, as well as its good predictive capabilities.",
publisher = "Wiley, Hoboken",
journal = "Journal of Chemometrics",
title = "Modeling of HILIC retention behavior with theoretical models and new spline interpolation technique",
volume = "31",
number = "9",
doi = "10.1002/cem.2910"
}

Tumpa, A., Misković, S., Stanimirović, Z., Jančić-Stojanović, B.,& Medenica, M.. (2017). Modeling of HILIC retention behavior with theoretical models and new spline interpolation technique. in Journal of Chemometrics
Wiley, Hoboken., 31(9).
https://doi.org/10.1002/cem.2910

Tumpa A, Misković S, Stanimirović Z, Jančić-Stojanović B, Medenica M. Modeling of HILIC retention behavior with theoretical models and new spline interpolation technique. in Journal of Chemometrics. 2017;31(9).
doi:10.1002/cem.2910 .

Tumpa, Anja, Misković, Stefan, Stanimirović, Zorica, Jančić-Stojanović, Biljana, Medenica, Mirjana, "Modeling of HILIC retention behavior with theoretical models and new spline interpolation technique" in Journal of Chemometrics, 31, no. 9 (2017),
https://doi.org/10.1002/cem.2910 . .

TY  - JOUR
AU  - Tumpa, Anja
AU  - Kalinić, Marko
AU  - Jovanović, Predrag
AU  - Erić, Slavica
AU  - Rakić, Tijana
AU  - Jančić-Stojanović, Biljana
AU  - Medenica, Mirjana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2650
AB  - In this article, retention modeling of eight aminopyridines (synthesized and characterized at the Faculty of Pharmacy) in reversed-phase high performance liquid chromatography (RP-HPLC) was performed. No data related to their retention in the RP-HPLC system were found. Knowing that, it was recognized as very important to describe their retention behavior. The influences of pH of the mobile phase and the organic modifier content on the retention factors were investigated. Two theoretical models for the dependence of retention factor of organic modifier content were tested. Then, the most reliable and accurate prediction of log k was created, testing multiple linear regression model-quantitative structure-retention relationships (MLR-QSRR) and support vector regression machine-quantitative structure-retention relationships (SVM-QSRR). Initially, 400 descriptors were calculated, but four of them (POM, log D, M-SZX/RZX and m-RPCG) were included in the models. SVM-QSRR performed significantly better than the MLR model. Apart from aminopyridines, four structurally similar substances (indapamide, gliclazide, sulfamethoxazole and furosemide) were followed in the same chromatographic system. They were used as external validation set for the QSRR model (it performed well within its applicability domain, which was defined using a bounding box approach). After having described retention of eight aminopyridines with both theoretical and QSRR models, further investigations in this field can be conducted.
PB  - Oxford Univ Press Inc, Cary
T2  - Journal of Chromatographic Science
T1  - Theoretical Models and QSRR in Retention Modeling of Eight Aminopyridines
VL  - 54
IS  - 3
SP  - 436
EP  - 444
DO  - 10.1093/chromsci/bmv165
ER  - 

@article{
author = "Tumpa, Anja and Kalinić, Marko and Jovanović, Predrag and Erić, Slavica and Rakić, Tijana and Jančić-Stojanović, Biljana and Medenica, Mirjana",
year = "2016",
abstract = "In this article, retention modeling of eight aminopyridines (synthesized and characterized at the Faculty of Pharmacy) in reversed-phase high performance liquid chromatography (RP-HPLC) was performed. No data related to their retention in the RP-HPLC system were found. Knowing that, it was recognized as very important to describe their retention behavior. The influences of pH of the mobile phase and the organic modifier content on the retention factors were investigated. Two theoretical models for the dependence of retention factor of organic modifier content were tested. Then, the most reliable and accurate prediction of log k was created, testing multiple linear regression model-quantitative structure-retention relationships (MLR-QSRR) and support vector regression machine-quantitative structure-retention relationships (SVM-QSRR). Initially, 400 descriptors were calculated, but four of them (POM, log D, M-SZX/RZX and m-RPCG) were included in the models. SVM-QSRR performed significantly better than the MLR model. Apart from aminopyridines, four structurally similar substances (indapamide, gliclazide, sulfamethoxazole and furosemide) were followed in the same chromatographic system. They were used as external validation set for the QSRR model (it performed well within its applicability domain, which was defined using a bounding box approach). After having described retention of eight aminopyridines with both theoretical and QSRR models, further investigations in this field can be conducted.",
publisher = "Oxford Univ Press Inc, Cary",
journal = "Journal of Chromatographic Science",
title = "Theoretical Models and QSRR in Retention Modeling of Eight Aminopyridines",
volume = "54",
number = "3",
pages = "436-444",
doi = "10.1093/chromsci/bmv165"
}

Tumpa, A., Kalinić, M., Jovanović, P., Erić, S., Rakić, T., Jančić-Stojanović, B.,& Medenica, M.. (2016). Theoretical Models and QSRR in Retention Modeling of Eight Aminopyridines. in Journal of Chromatographic Science
Oxford Univ Press Inc, Cary., 54(3), 436-444.
https://doi.org/10.1093/chromsci/bmv165

Tumpa A, Kalinić M, Jovanović P, Erić S, Rakić T, Jančić-Stojanović B, Medenica M. Theoretical Models and QSRR in Retention Modeling of Eight Aminopyridines. in Journal of Chromatographic Science. 2016;54(3):436-444.
doi:10.1093/chromsci/bmv165 .

Tumpa, Anja, Kalinić, Marko, Jovanović, Predrag, Erić, Slavica, Rakić, Tijana, Jančić-Stojanović, Biljana, Medenica, Mirjana, "Theoretical Models and QSRR in Retention Modeling of Eight Aminopyridines" in Journal of Chromatographic Science, 54, no. 3 (2016):436-444,
https://doi.org/10.1093/chromsci/bmv165 . .

TY  - CONF
AU  - Milić, Jela
AU  - Radojković, Branko
AU  - Stojanović, Biljana
AU  - Drašković, Jasmina
AU  - Mirašević, Slavica
AU  - Đorđević, Sanela
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2734
PB  - Elsevier Science BV, Amsterdam
C3  - International Journal of Pharmaceutics
T1  - Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules
VL  - 511
IS  - 2
SP  - 1147
EP  - 1148
DO  - 10.1016/j.ijpharm.2016.06.107
ER  - 

@conference{
author = "Milić, Jela and Radojković, Branko and Stojanović, Biljana and Drašković, Jasmina and Mirašević, Slavica and Đorđević, Sanela",
year = "2016",
publisher = "Elsevier Science BV, Amsterdam",
journal = "International Journal of Pharmaceutics",
title = "Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules",
volume = "511",
number = "2",
pages = "1147-1148",
doi = "10.1016/j.ijpharm.2016.06.107"
}

Milić, J., Radojković, B., Stojanović, B., Drašković, J., Mirašević, S.,& Đorđević, S.. (2016). Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules. in International Journal of Pharmaceutics
Elsevier Science BV, Amsterdam., 511(2), 1147-1148.
https://doi.org/10.1016/j.ijpharm.2016.06.107

Milić J, Radojković B, Stojanović B, Drašković J, Mirašević S, Đorđević S. Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules. in International Journal of Pharmaceutics. 2016;511(2):1147-1148.
doi:10.1016/j.ijpharm.2016.06.107 .

Milić, Jela, Radojković, Branko, Stojanović, Biljana, Drašković, Jasmina, Mirašević, Slavica, Đorđević, Sanela, "Investigation of omeprazole stability in oral suspensions for pediatric use prepared extemporaneously from omeprazole capsules" in International Journal of Pharmaceutics, 511, no. 2 (2016):1147-1148,
https://doi.org/10.1016/j.ijpharm.2016.06.107 . .

TY  - JOUR
AU  - Delević, Veselin
AU  - Zejnilović, R.M
AU  - Jančić-Stojanović, Biljana
AU  - Đorđević, Brižita
AU  - Tokić, Z.N
AU  - Zrnić-Ćirić, Milica
AU  - Stanković, Ivan
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2730
AB  - Acrylamide is toxic and probably carcinogenic compound, made as a result of high-temperature thermal treatment of carbohydrate-rich foodstuffs. In this article a method is improved for the extraction and quantitation of acrylamide in foods produced based on corn flour that are represented in our traditional diet. Acrylamide extraction was carried out using reduced volume of saturated solution of bromine water and the GC–MS method for the quantification was shown. Quantification of acrylamide was preceded by: sample homogenization, acrylamide extraction using water, extract purification using solid phase extraction, bromination, using a reduced volume of bromine water solution, dehydrobromination with sodium thiosulfate and transformation of dibromopropenamide in 2,3,2-bromopropenamide using triethylamine. Regression and correlation analysis were applied for the probability level of 0.05. Calibration is performed in the concentration range 5–80 ug/kg with a detection limit 6.86 mg/kg and the limits of quantification 10.78 ug/kg and the coefficient of determination R2 > 0.999. Calibration curve was obtained: y = 0.069x + 0.038. Recovery values were an average from 97 to 110%. Proposed GC–MS method is simple, precise and reliable for the determination of acrylamide in the samples of thermal treated foods. Our results show that the tested foods quantify the presence of acrylamide in concentrations of 18 to 77 mg/kg acrylamide depending on whether the food was prepared by cooking or baking.
PB  - Savez hemijskih inženjera, Beograd
T2  - Hemijska industrija
T1  - Quantification of acrylamide in foods selected by using gas chromatography tandem mass spectrometry
T1  - Kvantifikacija akrilamida u izabranim namirnicama primenom gasne hromatografije u tandemu sa masenom spektrometrijom
VL  - 70
IS  - 2
SP  - 209
EP  - 215
DO  - 10.2298/HEMIND150225027D
ER  - 

@article{
author = "Delević, Veselin and Zejnilović, R.M and Jančić-Stojanović, Biljana and Đorđević, Brižita and Tokić, Z.N and Zrnić-Ćirić, Milica and Stanković, Ivan",
year = "2016",
abstract = "Acrylamide is toxic and probably carcinogenic compound, made as a result of high-temperature thermal treatment of carbohydrate-rich foodstuffs. In this article a method is improved for the extraction and quantitation of acrylamide in foods produced based on corn flour that are represented in our traditional diet. Acrylamide extraction was carried out using reduced volume of saturated solution of bromine water and the GC–MS method for the quantification was shown. Quantification of acrylamide was preceded by: sample homogenization, acrylamide extraction using water, extract purification using solid phase extraction, bromination, using a reduced volume of bromine water solution, dehydrobromination with sodium thiosulfate and transformation of dibromopropenamide in 2,3,2-bromopropenamide using triethylamine. Regression and correlation analysis were applied for the probability level of 0.05. Calibration is performed in the concentration range 5–80 ug/kg with a detection limit 6.86 mg/kg and the limits of quantification 10.78 ug/kg and the coefficient of determination R2 > 0.999. Calibration curve was obtained: y = 0.069x + 0.038. Recovery values were an average from 97 to 110%. Proposed GC–MS method is simple, precise and reliable for the determination of acrylamide in the samples of thermal treated foods. Our results show that the tested foods quantify the presence of acrylamide in concentrations of 18 to 77 mg/kg acrylamide depending on whether the food was prepared by cooking or baking.",
publisher = "Savez hemijskih inženjera, Beograd",
journal = "Hemijska industrija",
title = "Quantification of acrylamide in foods selected by using gas chromatography tandem mass spectrometry, Kvantifikacija akrilamida u izabranim namirnicama primenom gasne hromatografije u tandemu sa masenom spektrometrijom",
volume = "70",
number = "2",
pages = "209-215",
doi = "10.2298/HEMIND150225027D"
}

Delević, V., Zejnilović, R.M, Jančić-Stojanović, B., Đorđević, B., Tokić, Z.N, Zrnić-Ćirić, M.,& Stanković, I.. (2016). Quantification of acrylamide in foods selected by using gas chromatography tandem mass spectrometry. in Hemijska industrija
Savez hemijskih inženjera, Beograd., 70(2), 209-215.
https://doi.org/10.2298/HEMIND150225027D

Delević V, Zejnilović R, Jančić-Stojanović B, Đorđević B, Tokić Z, Zrnić-Ćirić M, Stanković I. Quantification of acrylamide in foods selected by using gas chromatography tandem mass spectrometry. in Hemijska industrija. 2016;70(2):209-215.
doi:10.2298/HEMIND150225027D .

Delević, Veselin, Zejnilović, R.M, Jančić-Stojanović, Biljana, Đorđević, Brižita, Tokić, Z.N, Zrnić-Ćirić, Milica, Stanković, Ivan, "Quantification of acrylamide in foods selected by using gas chromatography tandem mass spectrometry" in Hemijska industrija, 70, no. 2 (2016):209-215,
https://doi.org/10.2298/HEMIND150225027D . .

TY  - JOUR
AU  - Tumpa, Anja
AU  - Miladinović, Tamara
AU  - Rakić, Tijana
AU  - Stajić, Ana
AU  - Jančić-Stojanović, Biljana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2567
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3444
AB  - A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150mmx4.6mm, 5 mu m particle size column; a methanol -68.3mmolL(-1) potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1mL min(-1), a column temperature of 25 degrees C, and ultraviolet detection at 254nm.
PB  - Taylor & Francis Inc, Philadelphia
T2  - Analytical Letters
T1  - Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography
VL  - 49
IS  - 4
SP  - 445
EP  - 457
DO  - 10.1080/00032719.2015.1075131
ER  - 

@article{
author = "Tumpa, Anja and Miladinović, Tamara and Rakić, Tijana and Stajić, Ana and Jančić-Stojanović, Biljana",
year = "2016",
abstract = "A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150mmx4.6mm, 5 mu m particle size column; a methanol -68.3mmolL(-1) potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1mL min(-1), a column temperature of 25 degrees C, and ultraviolet detection at 254nm.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Analytical Letters",
title = "Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography",
volume = "49",
number = "4",
pages = "445-457",
doi = "10.1080/00032719.2015.1075131"
}

Tumpa, A., Miladinović, T., Rakić, T., Stajić, A.,& Jančić-Stojanović, B.. (2016). Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography. in Analytical Letters
Taylor & Francis Inc, Philadelphia., 49(4), 445-457.
https://doi.org/10.1080/00032719.2015.1075131

Tumpa A, Miladinović T, Rakić T, Stajić A, Jančić-Stojanović B. Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography. in Analytical Letters. 2016;49(4):445-457.
doi:10.1080/00032719.2015.1075131 .

Tumpa, Anja, Miladinović, Tamara, Rakić, Tijana, Stajić, Ana, Jančić-Stojanović, Biljana, "Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography" in Analytical Letters, 49, no. 4 (2016):445-457,
https://doi.org/10.1080/00032719.2015.1075131 . .

TY  - JOUR
AU  - Maksić, Jelena
AU  - Tumpa, Anja
AU  - Popović, Igor
AU  - Jančić-Stojanović, Biljana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2662
AB  - The purpose of the present research was to conduct stress degradation studies on the olopatadine hydrochloride, an antiallergic drug, using the hydrophilic interaction liquid chromatography (HILIC). HILIC requires the utilization of polar and moderately polar stationary phases and aqueous-organic mobile phase usually containing more than 70% of organic solvent. In this study, olopatadine hydrochloride was subjected to acid and base hydrolysis, oxidation and thermolytic degradation in order to estimate its stability under different stress conditions recommended by ICHQ1A (R2) guideline. Degree of degradation was followed by HILIC method. The chromatographic conditions were: column Betasil Cyano (100 mmx4.6 mm, 5 mu m particle size), mobile phase consisted of acetonitrile and ammonium acetate 5 mM (pH adjusted to 4.50) in ratio 85: 15 V/V, flow rate was 1 mL min(-1), column temperature was set at 30 degrees C and detection was performed at 257 nm. Results obtained for stress studies indicated that olopatadine hydrochloride underwent transformation under acidic and oxidative (30% hydrogen peroxyde) conditions showing high degree of degradation. Furthermore, it was found that olopatadine hydrochloride is relatively stable when exposed to thermal (60 degrees C) and basic (1 M NaOH) conditions. Therewith, kinetics of degradation reaction was determined with an aim to define the corresponding reaction rate constants and half-lives. Firstly, the order of the reaction was evaluated experimentally using the integral method. Based on the calculated values of the correlation coefficients, it was shown that the acidic, basic and oxidative degradation are the second-order reaction. High stability under basic conditions was achieved on the basis of the great degradation half-life values. Also, it has been verified that acidic degradation is the fastest reaction.
PB  - Savez hemijskih inženjera, Beograd
T2  - Hemijska industrija
T1  - Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]
VL  - 70
IS  - 3
SP  - 339
EP  - 346
DO  - 10.2298/HEMIND150404039M
ER  - 

@article{
author = "Maksić, Jelena and Tumpa, Anja and Popović, Igor and Jančić-Stojanović, Biljana",
year = "2016",
abstract = "The purpose of the present research was to conduct stress degradation studies on the olopatadine hydrochloride, an antiallergic drug, using the hydrophilic interaction liquid chromatography (HILIC). HILIC requires the utilization of polar and moderately polar stationary phases and aqueous-organic mobile phase usually containing more than 70% of organic solvent. In this study, olopatadine hydrochloride was subjected to acid and base hydrolysis, oxidation and thermolytic degradation in order to estimate its stability under different stress conditions recommended by ICHQ1A (R2) guideline. Degree of degradation was followed by HILIC method. The chromatographic conditions were: column Betasil Cyano (100 mmx4.6 mm, 5 mu m particle size), mobile phase consisted of acetonitrile and ammonium acetate 5 mM (pH adjusted to 4.50) in ratio 85: 15 V/V, flow rate was 1 mL min(-1), column temperature was set at 30 degrees C and detection was performed at 257 nm. Results obtained for stress studies indicated that olopatadine hydrochloride underwent transformation under acidic and oxidative (30% hydrogen peroxyde) conditions showing high degree of degradation. Furthermore, it was found that olopatadine hydrochloride is relatively stable when exposed to thermal (60 degrees C) and basic (1 M NaOH) conditions. Therewith, kinetics of degradation reaction was determined with an aim to define the corresponding reaction rate constants and half-lives. Firstly, the order of the reaction was evaluated experimentally using the integral method. Based on the calculated values of the correlation coefficients, it was shown that the acidic, basic and oxidative degradation are the second-order reaction. High stability under basic conditions was achieved on the basis of the great degradation half-life values. Also, it has been verified that acidic degradation is the fastest reaction.",
publisher = "Savez hemijskih inženjera, Beograd",
journal = "Hemijska industrija",
title = "Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]",
volume = "70",
number = "3",
pages = "339-346",
doi = "10.2298/HEMIND150404039M"
}

Maksić, J., Tumpa, A., Popović, I.,& Jančić-Stojanović, B.. (2016). Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]. in Hemijska industrija
Savez hemijskih inženjera, Beograd., 70(3), 339-346.
https://doi.org/10.2298/HEMIND150404039M

Maksić J, Tumpa A, Popović I, Jančić-Stojanović B. Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]. in Hemijska industrija. 2016;70(3):339-346.
doi:10.2298/HEMIND150404039M .

Maksić, Jelena, Tumpa, Anja, Popović, Igor, Jančić-Stojanović, Biljana, "Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]" in Hemijska industrija, 70, no. 3 (2016):339-346,
https://doi.org/10.2298/HEMIND150404039M . .

TY  - JOUR
AU  - Maksić, Jelena
AU  - Tumpa, Anja
AU  - Stajić, Ana
AU  - Jovanović, Marko
AU  - Rakić, Tijana
AU  - Jančić-Stojanović, Biljana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2604
AB  - In this paper separation of granisetron and its two related substances in HILIC mode is presented. Separation was done on silica column derivatized with sulfoalkylbetaine groups (ZIC-HILIC). Firstly, retention mechanisms were assessed whereby retention factors of substances were followed in wide range of acetonitrile content (80-97%), at constant concentration of aqueous buffer (10 mM) as well as at constant pH value of 3.0. Further, in order to developed optimal HILIC method, Design of Experiments (DoE) methodology was applied. For optimization full factorial design 32 was employed. Influence of acetonitrile content and ammonium acetate concentration were investigated while pH of the water phase was kept at 3.3. Adequacy of obtained mathematical models was confirmed by ANOVA. Optimization goals (alpha > 1.15 and minimal run time) were accomplished with 94.7% of acetonitrile in mobile phase and 70 mM of ammonium acetate in water phase. Optimal point was in the middle of defined Design Space. In the next phase, robustness was experimetally tested by Rechtschaffen design. The investigated factors and their levels were: acetonitrile content (+/- 1%), ammonium acetate molarity in water phase (+/- 2 mM), pH value of water phase (+/- 0.2) and column temperature (+/- 4 degrees C). The validation scope included selectivity, linearity, accuracy and precision as well as determination of limit of detection (LOD) and limit of quantification (LOQ) for the related substances. Additionally, the validation acceptance criteria were met in all cases. Finally, the proposed method could be successfully utilized for estimation of granisetron HCl and its related substances in tablets and parenteral dosage forms, as well as for monitoring degradation under various stress conditions.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Hydrophilic interaction liquid chromatography in analysis of granisetron HCl and its related substances. Retention mechanisms and method development
VL  - 123
SP  - 93
EP  - 103
DO  - 10.1016/j.jpba.2016.02.010
ER  - 

@article{
author = "Maksić, Jelena and Tumpa, Anja and Stajić, Ana and Jovanović, Marko and Rakić, Tijana and Jančić-Stojanović, Biljana",
year = "2016",
abstract = "In this paper separation of granisetron and its two related substances in HILIC mode is presented. Separation was done on silica column derivatized with sulfoalkylbetaine groups (ZIC-HILIC). Firstly, retention mechanisms were assessed whereby retention factors of substances were followed in wide range of acetonitrile content (80-97%), at constant concentration of aqueous buffer (10 mM) as well as at constant pH value of 3.0. Further, in order to developed optimal HILIC method, Design of Experiments (DoE) methodology was applied. For optimization full factorial design 32 was employed. Influence of acetonitrile content and ammonium acetate concentration were investigated while pH of the water phase was kept at 3.3. Adequacy of obtained mathematical models was confirmed by ANOVA. Optimization goals (alpha > 1.15 and minimal run time) were accomplished with 94.7% of acetonitrile in mobile phase and 70 mM of ammonium acetate in water phase. Optimal point was in the middle of defined Design Space. In the next phase, robustness was experimetally tested by Rechtschaffen design. The investigated factors and their levels were: acetonitrile content (+/- 1%), ammonium acetate molarity in water phase (+/- 2 mM), pH value of water phase (+/- 0.2) and column temperature (+/- 4 degrees C). The validation scope included selectivity, linearity, accuracy and precision as well as determination of limit of detection (LOD) and limit of quantification (LOQ) for the related substances. Additionally, the validation acceptance criteria were met in all cases. Finally, the proposed method could be successfully utilized for estimation of granisetron HCl and its related substances in tablets and parenteral dosage forms, as well as for monitoring degradation under various stress conditions.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Hydrophilic interaction liquid chromatography in analysis of granisetron HCl and its related substances. Retention mechanisms and method development",
volume = "123",
pages = "93-103",
doi = "10.1016/j.jpba.2016.02.010"
}

Maksić, J., Tumpa, A., Stajić, A., Jovanović, M., Rakić, T.,& Jančić-Stojanović, B.. (2016). Hydrophilic interaction liquid chromatography in analysis of granisetron HCl and its related substances. Retention mechanisms and method development. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 123, 93-103.
https://doi.org/10.1016/j.jpba.2016.02.010

Maksić J, Tumpa A, Stajić A, Jovanović M, Rakić T, Jančić-Stojanović B. Hydrophilic interaction liquid chromatography in analysis of granisetron HCl and its related substances. Retention mechanisms and method development. in Journal of Pharmaceutical and Biomedical Analysis. 2016;123:93-103.
doi:10.1016/j.jpba.2016.02.010 .

Maksić, Jelena, Tumpa, Anja, Stajić, Ana, Jovanović, Marko, Rakić, Tijana, Jančić-Stojanović, Biljana, "Hydrophilic interaction liquid chromatography in analysis of granisetron HCl and its related substances. Retention mechanisms and method development" in Journal of Pharmaceutical and Biomedical Analysis, 123 (2016):93-103,
https://doi.org/10.1016/j.jpba.2016.02.010 . .

TY  - JOUR
AU  - Tumpa, Anja
AU  - Miladinović, Tamara
AU  - Rakić, Tijana
AU  - Stajić, Ana
AU  - Jančić-Stojanović, Biljana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2567
AB  - A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150mmx4.6mm, 5 mu m particle size column; a methanol -68.3mmolL(-1) potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1mL min(-1), a column temperature of 25 degrees C, and ultraviolet detection at 254nm.
PB  - Taylor & Francis Inc, Philadelphia
T2  - Analytical Letters
T1  - Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography
VL  - 49
IS  - 4
SP  - 445
EP  - 457
DO  - 10.1080/00032719.2015.1075131
ER  - 

@article{
author = "Tumpa, Anja and Miladinović, Tamara and Rakić, Tijana and Stajić, Ana and Jančić-Stojanović, Biljana",
year = "2016",
abstract = "A liquid chromatography method is reported for the determination of diclofenac potassium and its impurities using Quality by Design criteria. Central composite design was used for the investigation of the influence of critical parameters on performance that included the methanol concentration in the mobile phase, the pH of the aqueous phase, and the potassium dihydrogen phosphate concentration in the aqueous phase. Mathematical models enabled theoretical examination of experimental space to achieve maximal separation in minimal analysis time. A Monte Carlo simulation was used to evaluate the risk of uncertainty in model predictions, to adjusting process parameters, and to identify design space. Fractional factorial design was employed for robustness testing and method was fully validated. Optimal conditions were a C18 150mmx4.6mm, 5 mu m particle size column; a methanol -68.3mmolL(-1) potassium dihydrogenphosphate (68.7:31.3, v/v) mobile phase at pH 3.0, a flow rate of 1mL min(-1), a column temperature of 25 degrees C, and ultraviolet detection at 254nm.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Analytical Letters",
title = "Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography",
volume = "49",
number = "4",
pages = "445-457",
doi = "10.1080/00032719.2015.1075131"
}

Tumpa, A., Miladinović, T., Rakić, T., Stajić, A.,& Jančić-Stojanović, B.. (2016). Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography. in Analytical Letters
Taylor & Francis Inc, Philadelphia., 49(4), 445-457.
https://doi.org/10.1080/00032719.2015.1075131

Tumpa A, Miladinović T, Rakić T, Stajić A, Jančić-Stojanović B. Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography. in Analytical Letters. 2016;49(4):445-457.
doi:10.1080/00032719.2015.1075131 .

Tumpa, Anja, Miladinović, Tamara, Rakić, Tijana, Stajić, Ana, Jančić-Stojanović, Biljana, "Quality by Design Determination of Diclofenac Potassium and its Impurities by High-Performance Liquid Chromatography" in Analytical Letters, 49, no. 4 (2016):445-457,
https://doi.org/10.1080/00032719.2015.1075131 . .

TY  - JOUR
AU  - Dobričić, Vladimir
AU  - Vulović-Tadić, Miljana
AU  - Jančić-Stojanović, Biljana
AU  - Vladimirov, Sote
AU  - Čudina, Olivera
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2555
AB  - In this paper optimization and validation of a new RP-HPLC method for simultaneous determination of bisoprolol fumarate, hydrochlorothiazide and impurities A, L, K and B are presented. Factors which could have significant influence on separation were selected: percentage of mobile phase B [acetonitrile-ammonium dihydrogen phosphate/orthophosphoric acid buffer solution (80:20, v/v)] at defined t (1) and t (2) of the gradient, ammonium dihydrogen phosphate concentration and pH value of the buffer solution (mobile phase A). Selected factors were varied according to Box-Behnken plan of experiments and their influence on critical pairs separation was investigated. DerringerA ' s desirability function was used for selection of optimal chromatographic conditions. Finally, optimal values of investigated factors were 34.4 % (t (1)) and 38.0 % (t (2)) of mobile phase B, 46.5 mM ammonium dihydrogen phosphate concentration and pH 3.35. The method was successfully validated according to ICH guidelines acceptance criteria for robustness, selectivity, linearity, accuracy and precision. Small variations of selected chromatographic parameters did not affect qualitative and quantitative system responses significantly, which proved the method's robustness. Limits of quantification (LOQ) and detection (LOD) for impurities were determined and LOQ values were the first points in linearity testing. Linearity was confirmed by r a parts per thousand yen 0.9945 (impurities) and r = 0.9998 (active substances). Accuracy was confirmed by calculated recoveries [93.5-107.1 % (impurities) and 98.1-101.9 % (active substances)]. Precision was tested at three levels: injection repeatability, analysis repeatability and intermediate precision. Calculated relative standard deviations were less than 1, 2 and 3 %, respectively. Finally, the method was applied to real sample analysis.
PB  - Springer Heidelberg, Heidelberg
T2  - Chromatographia
T1  - Desirability Based Optimization and Validation of New RP-HPLC Method for Simultaneous Determination of Bisoprolol Fumarate, Hydrochlorothiazide and Their Impurities
VL  - 79
IS  - 9-10
SP  - 571
EP  - 579
DO  - 10.1007/s10337-016-3065-5
ER  - 

@article{
author = "Dobričić, Vladimir and Vulović-Tadić, Miljana and Jančić-Stojanović, Biljana and Vladimirov, Sote and Čudina, Olivera",
year = "2016",
abstract = "In this paper optimization and validation of a new RP-HPLC method for simultaneous determination of bisoprolol fumarate, hydrochlorothiazide and impurities A, L, K and B are presented. Factors which could have significant influence on separation were selected: percentage of mobile phase B [acetonitrile-ammonium dihydrogen phosphate/orthophosphoric acid buffer solution (80:20, v/v)] at defined t (1) and t (2) of the gradient, ammonium dihydrogen phosphate concentration and pH value of the buffer solution (mobile phase A). Selected factors were varied according to Box-Behnken plan of experiments and their influence on critical pairs separation was investigated. DerringerA ' s desirability function was used for selection of optimal chromatographic conditions. Finally, optimal values of investigated factors were 34.4 % (t (1)) and 38.0 % (t (2)) of mobile phase B, 46.5 mM ammonium dihydrogen phosphate concentration and pH 3.35. The method was successfully validated according to ICH guidelines acceptance criteria for robustness, selectivity, linearity, accuracy and precision. Small variations of selected chromatographic parameters did not affect qualitative and quantitative system responses significantly, which proved the method's robustness. Limits of quantification (LOQ) and detection (LOD) for impurities were determined and LOQ values were the first points in linearity testing. Linearity was confirmed by r a parts per thousand yen 0.9945 (impurities) and r = 0.9998 (active substances). Accuracy was confirmed by calculated recoveries [93.5-107.1 % (impurities) and 98.1-101.9 % (active substances)]. Precision was tested at three levels: injection repeatability, analysis repeatability and intermediate precision. Calculated relative standard deviations were less than 1, 2 and 3 %, respectively. Finally, the method was applied to real sample analysis.",
publisher = "Springer Heidelberg, Heidelberg",
journal = "Chromatographia",
title = "Desirability Based Optimization and Validation of New RP-HPLC Method for Simultaneous Determination of Bisoprolol Fumarate, Hydrochlorothiazide and Their Impurities",
volume = "79",
number = "9-10",
pages = "571-579",
doi = "10.1007/s10337-016-3065-5"
}

Dobričić, V., Vulović-Tadić, M., Jančić-Stojanović, B., Vladimirov, S.,& Čudina, O.. (2016). Desirability Based Optimization and Validation of New RP-HPLC Method for Simultaneous Determination of Bisoprolol Fumarate, Hydrochlorothiazide and Their Impurities. in Chromatographia
Springer Heidelberg, Heidelberg., 79(9-10), 571-579.
https://doi.org/10.1007/s10337-016-3065-5

Dobričić V, Vulović-Tadić M, Jančić-Stojanović B, Vladimirov S, Čudina O. Desirability Based Optimization and Validation of New RP-HPLC Method for Simultaneous Determination of Bisoprolol Fumarate, Hydrochlorothiazide and Their Impurities. in Chromatographia. 2016;79(9-10):571-579.
doi:10.1007/s10337-016-3065-5 .

Dobričić, Vladimir, Vulović-Tadić, Miljana, Jančić-Stojanović, Biljana, Vladimirov, Sote, Čudina, Olivera, "Desirability Based Optimization and Validation of New RP-HPLC Method for Simultaneous Determination of Bisoprolol Fumarate, Hydrochlorothiazide and Their Impurities" in Chromatographia, 79, no. 9-10 (2016):571-579,
https://doi.org/10.1007/s10337-016-3065-5 . .

TY  - JOUR
AU  - Terzić, Jelena
AU  - Popović, Igor
AU  - Stajić, Ana
AU  - Tumpa, Anja
AU  - Jančić-Stojanović, Biljana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2548
AB  - This paper deals with the development of hydrophilic interaction liquid chromatographic (HILIC) method for the analysis of bilastine and its degradation impurities following Analytical Quality by Design approach. It is the first time that the method for bilastine and its impurities is proposed. The main objective was to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Critical process parameters which have the most influence on method performance were defined as acetonitrile content in the mobile phase, pH of the aqueous phase and ammonium acetate concentration in the aqueous phase. Box-Behnken design was applied for establishing a relationship between critical process parameters and critical quality attributes. The defined mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing and the method is validated to verify the adequacy of selected optimal conditions: the analytical column Luna (R) HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile aqueous phase (50 mM ammonium acetate, pH adjusted to 5.3 with glacial acetic acid) (90.5:9.5, v/v); column temperature 30 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 275 nm.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method
VL  - 125
SP  - 385
EP  - 393
DO  - 10.1016/j.jpba.2016.04.022
ER  - 

@article{
author = "Terzić, Jelena and Popović, Igor and Stajić, Ana and Tumpa, Anja and Jančić-Stojanović, Biljana",
year = "2016",
abstract = "This paper deals with the development of hydrophilic interaction liquid chromatographic (HILIC) method for the analysis of bilastine and its degradation impurities following Analytical Quality by Design approach. It is the first time that the method for bilastine and its impurities is proposed. The main objective was to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Critical process parameters which have the most influence on method performance were defined as acetonitrile content in the mobile phase, pH of the aqueous phase and ammonium acetate concentration in the aqueous phase. Box-Behnken design was applied for establishing a relationship between critical process parameters and critical quality attributes. The defined mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing and the method is validated to verify the adequacy of selected optimal conditions: the analytical column Luna (R) HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile aqueous phase (50 mM ammonium acetate, pH adjusted to 5.3 with glacial acetic acid) (90.5:9.5, v/v); column temperature 30 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 275 nm.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method",
volume = "125",
pages = "385-393",
doi = "10.1016/j.jpba.2016.04.022"
}

Terzić, J., Popović, I., Stajić, A., Tumpa, A.,& Jančić-Stojanović, B.. (2016). Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 125, 385-393.
https://doi.org/10.1016/j.jpba.2016.04.022

Terzić J, Popović I, Stajić A, Tumpa A, Jančić-Stojanović B. Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. in Journal of Pharmaceutical and Biomedical Analysis. 2016;125:385-393.
doi:10.1016/j.jpba.2016.04.022 .

Terzić, Jelena, Popović, Igor, Stajić, Ana, Tumpa, Anja, Jančić-Stojanović, Biljana, "Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method" in Journal of Pharmaceutical and Biomedical Analysis, 125 (2016):385-393,
https://doi.org/10.1016/j.jpba.2016.04.022 . .

TY  - JOUR
AU  - Jančić-Stojanović, Biljana
AU  - Vemić, Sava
AU  - Elezović, Valentina
AU  - Petrović, Ana
AU  - Sinadinović, Zoran
AU  - Ivanović, Darko
AU  - Damjanović, Svetozar S.
AU  - Miljković, Branislava
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2438
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3432
AB  - A simple and reliable new HPLC method with UV detection has been developed and validated for simultaneous determination of mitotane and its two metabolites DDA and DDE. Method development was carried out utilizing systematical approach of the design of experiments (DoE) methodology. For estimation of factors influence on selected chromatographic responses and definition of the optimal chromatographic conditions, Box-Behnken experimental design was applied. The defined optimal separation conditions were: column Restek Ultra Aqua C-18 with pre-column Restek Ultra Aqua C-18 operating at temperature 35 degrees C; mixture of acetonitrile and 0.5% formic acid as mobile phase with 1.2mL min(-1) flow rate and detection at 230nm. As sample preparation method, liquid-liquid extraction was chosen. Method was fully validated and LOQ and LOD were experimentally determined. Finally, method was successfully applied for determination of mitotane and its metabolites in plasma samples of patients with adrenocortical carcinoma.
PB  - Taylor & Francis Inc, Philadelphia
T2  - Journal of Liquid Chromatography & Related Technologies
T1  - Development of New Liquid Chromatographic Method for Mitotane and Its Metabolites Determination in Human Plasma Employing Design of Experiments Methodology
VL  - 38
IS  - 14
SP  - 1371
EP  - 1378
DO  - 10.1080/10826076.2015.1057645
ER  - 

@article{
author = "Jančić-Stojanović, Biljana and Vemić, Sava and Elezović, Valentina and Petrović, Ana and Sinadinović, Zoran and Ivanović, Darko and Damjanović, Svetozar S. and Miljković, Branislava",
year = "2015",
abstract = "A simple and reliable new HPLC method with UV detection has been developed and validated for simultaneous determination of mitotane and its two metabolites DDA and DDE. Method development was carried out utilizing systematical approach of the design of experiments (DoE) methodology. For estimation of factors influence on selected chromatographic responses and definition of the optimal chromatographic conditions, Box-Behnken experimental design was applied. The defined optimal separation conditions were: column Restek Ultra Aqua C-18 with pre-column Restek Ultra Aqua C-18 operating at temperature 35 degrees C; mixture of acetonitrile and 0.5% formic acid as mobile phase with 1.2mL min(-1) flow rate and detection at 230nm. As sample preparation method, liquid-liquid extraction was chosen. Method was fully validated and LOQ and LOD were experimentally determined. Finally, method was successfully applied for determination of mitotane and its metabolites in plasma samples of patients with adrenocortical carcinoma.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Journal of Liquid Chromatography & Related Technologies",
title = "Development of New Liquid Chromatographic Method for Mitotane and Its Metabolites Determination in Human Plasma Employing Design of Experiments Methodology",
volume = "38",
number = "14",
pages = "1371-1378",
doi = "10.1080/10826076.2015.1057645"
}

Jančić-Stojanović, B., Vemić, S., Elezović, V., Petrović, A., Sinadinović, Z., Ivanović, D., Damjanović, S. S.,& Miljković, B.. (2015). Development of New Liquid Chromatographic Method for Mitotane and Its Metabolites Determination in Human Plasma Employing Design of Experiments Methodology. in Journal of Liquid Chromatography & Related Technologies
Taylor & Francis Inc, Philadelphia., 38(14), 1371-1378.
https://doi.org/10.1080/10826076.2015.1057645

Jančić-Stojanović B, Vemić S, Elezović V, Petrović A, Sinadinović Z, Ivanović D, Damjanović SS, Miljković B. Development of New Liquid Chromatographic Method for Mitotane and Its Metabolites Determination in Human Plasma Employing Design of Experiments Methodology. in Journal of Liquid Chromatography & Related Technologies. 2015;38(14):1371-1378.
doi:10.1080/10826076.2015.1057645 .

Jančić-Stojanović, Biljana, Vemić, Sava, Elezović, Valentina, Petrović, Ana, Sinadinović, Zoran, Ivanović, Darko, Damjanović, Svetozar S., Miljković, Branislava, "Development of New Liquid Chromatographic Method for Mitotane and Its Metabolites Determination in Human Plasma Employing Design of Experiments Methodology" in Journal of Liquid Chromatography & Related Technologies, 38, no. 14 (2015):1371-1378,
https://doi.org/10.1080/10826076.2015.1057645 . .

TY  - JOUR
AU  - Tumpa, Anja
AU  - Rakić, Tijana
AU  - Jovanović, Marko
AU  - Jančić-Stojanović, Biljana
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2332
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3443
AB  - The retention behavior of substances in hydrophilic interaction liquid chromatography (HILIC) is difficult to predict. Mixture investigated in this paper consists of acetylsalicylic acid, amlodipine, impurity A of amlodipine, and atenolol, a very often used combination in treatment of some cardiovascular diseases. Retention behavior dependence on the most influential chromatographic factors is described by mathematical models, with the special emphasis on pH of the mobile phase. D-optimal design is applied to generate more complex models and to obtain more accurate results. Comparison of Predicted R-2 values of quadratic and cubic model for pH dependence (0.847 and 0.934, respectively) shows that the cubic model has significantly better prediction ability than quadratic in the investigated system. After describing retention behavior, chemometrical tools (indirect modeling of complex chromatographic responses and grid point search optimization) are used to locate the optimal conditions for analyzed mixture in terms of satisfactory separation and minimal analysis duration. The optimal conditions are Column: Kinetex HILIC 100 A (100mmx4.5mm, 2.6 mu m particle size); injection volume: 5 mu L; flow rate: 1mLmin(-1); column temperature: 30 degrees C; detection wavelength: 254nm; mobile phase: acetonitrile-water phase (75mM ammonium acetate, pH 5.3) (91:9V/V).
PB  - Taylor & Francis Inc, Philadelphia
T2  - Journal of Liquid Chromatography & Related Technologies
T1  - Optimization of Chromatographic Separation of Acetylsalicylic Acid, Amlodipine, Impurity a of Amlodipine, and Atenolol in Hydrophilic Interaction Liquid Chromatography Employing DoE Methodology
VL  - 38
IS  - 16
SP  - 1555
EP  - 1560
DO  - 10.1080/10826076.2015.1077863
ER  - 

@article{
author = "Tumpa, Anja and Rakić, Tijana and Jovanović, Marko and Jančić-Stojanović, Biljana",
year = "2015",
abstract = "The retention behavior of substances in hydrophilic interaction liquid chromatography (HILIC) is difficult to predict. Mixture investigated in this paper consists of acetylsalicylic acid, amlodipine, impurity A of amlodipine, and atenolol, a very often used combination in treatment of some cardiovascular diseases. Retention behavior dependence on the most influential chromatographic factors is described by mathematical models, with the special emphasis on pH of the mobile phase. D-optimal design is applied to generate more complex models and to obtain more accurate results. Comparison of Predicted R-2 values of quadratic and cubic model for pH dependence (0.847 and 0.934, respectively) shows that the cubic model has significantly better prediction ability than quadratic in the investigated system. After describing retention behavior, chemometrical tools (indirect modeling of complex chromatographic responses and grid point search optimization) are used to locate the optimal conditions for analyzed mixture in terms of satisfactory separation and minimal analysis duration. The optimal conditions are Column: Kinetex HILIC 100 A (100mmx4.5mm, 2.6 mu m particle size); injection volume: 5 mu L; flow rate: 1mLmin(-1); column temperature: 30 degrees C; detection wavelength: 254nm; mobile phase: acetonitrile-water phase (75mM ammonium acetate, pH 5.3) (91:9V/V).",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Journal of Liquid Chromatography & Related Technologies",
title = "Optimization of Chromatographic Separation of Acetylsalicylic Acid, Amlodipine, Impurity a of Amlodipine, and Atenolol in Hydrophilic Interaction Liquid Chromatography Employing DoE Methodology",
volume = "38",
number = "16",
pages = "1555-1560",
doi = "10.1080/10826076.2015.1077863"
}

Tumpa, A., Rakić, T., Jovanović, M.,& Jančić-Stojanović, B.. (2015). Optimization of Chromatographic Separation of Acetylsalicylic Acid, Amlodipine, Impurity a of Amlodipine, and Atenolol in Hydrophilic Interaction Liquid Chromatography Employing DoE Methodology. in Journal of Liquid Chromatography & Related Technologies
Taylor & Francis Inc, Philadelphia., 38(16), 1555-1560.
https://doi.org/10.1080/10826076.2015.1077863

Tumpa A, Rakić T, Jovanović M, Jančić-Stojanović B. Optimization of Chromatographic Separation of Acetylsalicylic Acid, Amlodipine, Impurity a of Amlodipine, and Atenolol in Hydrophilic Interaction Liquid Chromatography Employing DoE Methodology. in Journal of Liquid Chromatography & Related Technologies. 2015;38(16):1555-1560.
doi:10.1080/10826076.2015.1077863 .

Tumpa, Anja, Rakić, Tijana, Jovanović, Marko, Jančić-Stojanović, Biljana, "Optimization of Chromatographic Separation of Acetylsalicylic Acid, Amlodipine, Impurity a of Amlodipine, and Atenolol in Hydrophilic Interaction Liquid Chromatography Employing DoE Methodology" in Journal of Liquid Chromatography & Related Technologies, 38, no. 16 (2015):1555-1560,
https://doi.org/10.1080/10826076.2015.1077863 . .

TY  - JOUR
AU  - Jovanović, Marko
AU  - Rakić, Tijana
AU  - Tumpa, Anja
AU  - Jančić-Stojanović, Biljana
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3418
AB  - This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities
VL  - 110
SP  - 42
EP  - 48
DO  - 10.1016/j.jpba.2015.02.046
ER  - 

@article{
author = "Jovanović, Marko and Rakić, Tijana and Tumpa, Anja and Jančić-Stojanović, Biljana",
year = "2015",
abstract = "This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities",
volume = "110",
pages = "42-48",
doi = "10.1016/j.jpba.2015.02.046"
}

Jovanović, M., Rakić, T., Tumpa, A.,& Jančić-Stojanović, B.. (2015). Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 110, 42-48.
https://doi.org/10.1016/j.jpba.2015.02.046

Jovanović M, Rakić T, Tumpa A, Jančić-Stojanović B. Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities. in Journal of Pharmaceutical and Biomedical Analysis. 2015;110:42-48.
doi:10.1016/j.jpba.2015.02.046 .

Jovanović, Marko, Rakić, Tijana, Tumpa, Anja, Jančić-Stojanović, Biljana, "Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities" in Journal of Pharmaceutical and Biomedical Analysis, 110 (2015):42-48,
https://doi.org/10.1016/j.jpba.2015.02.046 . .