Popović, Igor

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  • Popović, Igor (10)
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Author's Bibliography

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)

Terzić, Jelena; Popović, Igor; Tumpa, Anja; Stajić, Ana; Jančić-Stojanović, Biljana

(Elsevier Science BV, Amsterdam, 2017)

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 . .
2

Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]

Maksić, Jelena; Tumpa, Anja; Popović, Igor; Jančić-Stojanović, Biljana

(Savez hemijskih inženjera, Beograd, 2016)

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 . .
1

Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method

Terzić, Jelena; Popović, Igor; Stajić, Ana; Tumpa, Anja; Jančić-Stojanović, Biljana

(Elsevier Science BV, Amsterdam, 2016)

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 . .
45
31
43

Chromatographic Analysis of Olopatadine in Hydrophilic Interaction Liquid Chromatography

Maksić, Jelena; Jovanović, Marko; Rakić, Tijana; Popović, Igor; Ivanović, Darko; Jančić-Stojanović, Biljana

(Oxford Univ Press Inc, Cary, 2015)

TY  - JOUR
AU  - Maksić, Jelena
AU  - Jovanović, Marko
AU  - Rakić, Tijana
AU  - Popović, Igor
AU  - Ivanović, Darko
AU  - Jančić-Stojanović, Biljana
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2318
AB  - In this paper, chromatographic analysis of active substance olopatadine hydrochloride, which is used in eye drops as antihistaminic agent, and its impurity E isomer by hydrophilic interaction liquid chromatography (HILIC) and application of design of experiments (DoE) methodology are presented. In addition, benzalkonium chloride is very often used as a preservative in eye drops. Therefore, the evaluation of its chromatographic behavior in HILIC was carried out as well. In order to estimate chromatographic behavior and set optimal chromatographic conditions, DoE methodology was applied. After the selection of important chromatographic factors, Box-Behnken design was utilized, and on the basis of the obtained models factor effects were examined. Then, multi-objective robust optimization is performed aiming to obtain chromatographic conditions that comply with several quality criteria simultaneously: adequate and robust separation of critical peak pair and maximum retention of the first eluting peak. The optimal conditions are identified by using grid point search methodology. The experimental verification confirmed the adequacy of the defined optimal conditions. Finally, under optimal chromatographic conditions, the method was validated and applicability of the proposed method was confirmed.
PB  - Oxford Univ Press Inc, Cary
T2  - Journal of Chromatographic Science
T1  - Chromatographic Analysis of Olopatadine in Hydrophilic Interaction Liquid Chromatography
VL  - 53
IS  - 5
SP  - 680
EP  - 686
DO  - 10.1093/chromsci/bmu102
ER  - 
@article{
author = "Maksić, Jelena and Jovanović, Marko and Rakić, Tijana and Popović, Igor and Ivanović, Darko and Jančić-Stojanović, Biljana",
year = "2015",
abstract = "In this paper, chromatographic analysis of active substance olopatadine hydrochloride, which is used in eye drops as antihistaminic agent, and its impurity E isomer by hydrophilic interaction liquid chromatography (HILIC) and application of design of experiments (DoE) methodology are presented. In addition, benzalkonium chloride is very often used as a preservative in eye drops. Therefore, the evaluation of its chromatographic behavior in HILIC was carried out as well. In order to estimate chromatographic behavior and set optimal chromatographic conditions, DoE methodology was applied. After the selection of important chromatographic factors, Box-Behnken design was utilized, and on the basis of the obtained models factor effects were examined. Then, multi-objective robust optimization is performed aiming to obtain chromatographic conditions that comply with several quality criteria simultaneously: adequate and robust separation of critical peak pair and maximum retention of the first eluting peak. The optimal conditions are identified by using grid point search methodology. The experimental verification confirmed the adequacy of the defined optimal conditions. Finally, under optimal chromatographic conditions, the method was validated and applicability of the proposed method was confirmed.",
publisher = "Oxford Univ Press Inc, Cary",
journal = "Journal of Chromatographic Science",
title = "Chromatographic Analysis of Olopatadine in Hydrophilic Interaction Liquid Chromatography",
volume = "53",
number = "5",
pages = "680-686",
doi = "10.1093/chromsci/bmu102"
}
Maksić, J., Jovanović, M., Rakić, T., Popović, I., Ivanović, D.,& Jančić-Stojanović, B.. (2015). Chromatographic Analysis of Olopatadine in Hydrophilic Interaction Liquid Chromatography. in Journal of Chromatographic Science
Oxford Univ Press Inc, Cary., 53(5), 680-686.
https://doi.org/10.1093/chromsci/bmu102
Maksić J, Jovanović M, Rakić T, Popović I, Ivanović D, Jančić-Stojanović B. Chromatographic Analysis of Olopatadine in Hydrophilic Interaction Liquid Chromatography. in Journal of Chromatographic Science. 2015;53(5):680-686.
doi:10.1093/chromsci/bmu102 .
Maksić, Jelena, Jovanović, Marko, Rakić, Tijana, Popović, Igor, Ivanović, Darko, Jančić-Stojanović, Biljana, "Chromatographic Analysis of Olopatadine in Hydrophilic Interaction Liquid Chromatography" in Journal of Chromatographic Science, 53, no. 5 (2015):680-686,
https://doi.org/10.1093/chromsci/bmu102 . .
8
4
9

Aspects of DryLab® software application in chromatography methods optimization and robustness testing

Terzić, Jelena; Popović, Igor; Jančić-Stojanović, Biljana

(Savez farmaceutskih udruženja Srbije, Beograd, 2014)

TY  - JOUR
AU  - Terzić, Jelena
AU  - Popović, Igor
AU  - Jančić-Stojanović, Biljana
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2292
AB  - In this review article, aspects of DryLab® software application in liquid chromatography are given. Literature survey shows wide application of software for chromatography method development, optimization, as well as for robustness testing. Earlier versions of DryLab®software enabled the simultaneous monitoring of the impact of two parameters on the selected system response, as an upgraded version of the software provides significantly more opportunities. Namely, the new DryLab®software version enables fulfilling requirements given by Quality by Design (QbD) concept through a systematic approach to the development of chromatographic methods, and the construction of a 3D cube which provides the visualization of a Design Space. In addition, when running liquid chromatography methods on a routine basis software can be a useful tool for optimization process in order to minimize retention times and run time, as well as facilitating the transfer of a method (DryLab® data can be sent electronically). Finally, DryLab®software provides useful information about the method and can be applied to training of young analysts without performing experiments, while saving time, money, and laboratory instruments.
AB  - U preglednom radu prikazani su aspekti primene DryLab® softvera u tečnoj hromatografiji. Literaturni pregled pokazuje široku primenu softvera u fazi postavljanja nove hromatografske metode, optimizaciji, kao i u proceni robusnosti metode. Ranije verzije DryLab® softvera omogućavale su istovremeno praćenje uticaja dva faktora na odabrani odgovor sistema, dok unapređene verzije softvera daju značajno veće mogućnosti. Novije verzije DryLab® softvera omogućavaju ispunjavanje zahteva određenih Quality by Design (QbD) konceptom kroz sistematičan prilaz razvoju hromatografske metode, kao i kroz konstruisanje 3D kocke kojom se omogućava vizuelni prikaz Design space-a. Pored toga, u rutinskoj primeni metoda tečne hromatografije softver može biti koristan 'alat' za optimizaciju u cilju skraćenja retencionih vremena i trajanja analize, kao i olakšavanja transfera metoda (podaci dobijeni uz pomoć DryLab®-a se mogu slati elektronskim putem). Na kraju, upotrebom DryLab® softvera dobijaju se korisne informacije o metodi, a uz to može služiti za obučavanje mladih analitičara bez izvođenja eksperimenata, uz istovremenu uštedu vremena, novca i laboratorijske opreme.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Aspects of DryLab® software application in chromatography methods optimization and robustness testing
T1  - Aspekti primene DryLab® softvera u optimizaciji i proceni robusnosti hromatografskih metoda
VL  - 64
IS  - 3
SP  - 205
EP  - 219
DO  - 10.5937/arhfarm1403205T
ER  - 
@article{
author = "Terzić, Jelena and Popović, Igor and Jančić-Stojanović, Biljana",
year = "2014",
abstract = "In this review article, aspects of DryLab® software application in liquid chromatography are given. Literature survey shows wide application of software for chromatography method development, optimization, as well as for robustness testing. Earlier versions of DryLab®software enabled the simultaneous monitoring of the impact of two parameters on the selected system response, as an upgraded version of the software provides significantly more opportunities. Namely, the new DryLab®software version enables fulfilling requirements given by Quality by Design (QbD) concept through a systematic approach to the development of chromatographic methods, and the construction of a 3D cube which provides the visualization of a Design Space. In addition, when running liquid chromatography methods on a routine basis software can be a useful tool for optimization process in order to minimize retention times and run time, as well as facilitating the transfer of a method (DryLab® data can be sent electronically). Finally, DryLab®software provides useful information about the method and can be applied to training of young analysts without performing experiments, while saving time, money, and laboratory instruments., U preglednom radu prikazani su aspekti primene DryLab® softvera u tečnoj hromatografiji. Literaturni pregled pokazuje široku primenu softvera u fazi postavljanja nove hromatografske metode, optimizaciji, kao i u proceni robusnosti metode. Ranije verzije DryLab® softvera omogućavale su istovremeno praćenje uticaja dva faktora na odabrani odgovor sistema, dok unapređene verzije softvera daju značajno veće mogućnosti. Novije verzije DryLab® softvera omogućavaju ispunjavanje zahteva određenih Quality by Design (QbD) konceptom kroz sistematičan prilaz razvoju hromatografske metode, kao i kroz konstruisanje 3D kocke kojom se omogućava vizuelni prikaz Design space-a. Pored toga, u rutinskoj primeni metoda tečne hromatografije softver može biti koristan 'alat' za optimizaciju u cilju skraćenja retencionih vremena i trajanja analize, kao i olakšavanja transfera metoda (podaci dobijeni uz pomoć DryLab®-a se mogu slati elektronskim putem). Na kraju, upotrebom DryLab® softvera dobijaju se korisne informacije o metodi, a uz to može služiti za obučavanje mladih analitičara bez izvođenja eksperimenata, uz istovremenu uštedu vremena, novca i laboratorijske opreme.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Aspects of DryLab® software application in chromatography methods optimization and robustness testing, Aspekti primene DryLab® softvera u optimizaciji i proceni robusnosti hromatografskih metoda",
volume = "64",
number = "3",
pages = "205-219",
doi = "10.5937/arhfarm1403205T"
}
Terzić, J., Popović, I.,& Jančić-Stojanović, B.. (2014). Aspects of DryLab® software application in chromatography methods optimization and robustness testing. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 64(3), 205-219.
https://doi.org/10.5937/arhfarm1403205T
Terzić J, Popović I, Jančić-Stojanović B. Aspects of DryLab® software application in chromatography methods optimization and robustness testing. in Arhiv za farmaciju. 2014;64(3):205-219.
doi:10.5937/arhfarm1403205T .
Terzić, Jelena, Popović, Igor, Jančić-Stojanović, Biljana, "Aspects of DryLab® software application in chromatography methods optimization and robustness testing" in Arhiv za farmaciju, 64, no. 3 (2014):205-219,
https://doi.org/10.5937/arhfarm1403205T . .

Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities

Jančić-Stojanović, Biljana; Popović, Igor; Malenović, Anđelija; Ivanović, Darko; Medenica, Mirjana

(Springer Heidelberg, Heidelberg, 2010)

TY  - JOUR
AU  - Jančić-Stojanović, Biljana
AU  - Popović, Igor
AU  - Malenović, Anđelija
AU  - Ivanović, Darko
AU  - Medenica, Mirjana
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1416
AB  - In this paper optimization of chromatographic retention of ramipril and its five impurities employing factorial design is presented. On the basis of preliminary experiments three factors were chosen as inputs (acetonitrile content, pH of the mobile phase and buffer concentration) and retention factor as output. As optimal full factorial design 2(3) was chosen, factors were examined at two different levels "low" and "high". Three replications at zero level were added in order to check linearity and complete statistical tests. Relationship between inputs and output is presented in form of second order interaction model. Adequacy of model was explained using analysis of variance. After analysis of results optimal chromatographic conditions were set. Separations were conducted on a C(18) column with a mixture of acetonitrile and water phase (TEA in potassium dihydrogen phosphate) in ratio 23:77 v/v. Finally, the LC method was validated and applied for quality control analysis of commercially available tablets. The proposed method is simpler and faster as compared to existing official methods and therefore more adequate for routine control of ramipril during shelf life. Also a general approach which includes factorial design in method optimization offers a possibility for predicting and following the chromatographic behavior of such complex mixtures.
PB  - Springer Heidelberg, Heidelberg
T2  - Chromatographia
T1  - Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities
VL  - 71
IS  - 9-10
SP  - 799
EP  - 804
DO  - 10.1365/s10337-010-1546-5
ER  - 
@article{
author = "Jančić-Stojanović, Biljana and Popović, Igor and Malenović, Anđelija and Ivanović, Darko and Medenica, Mirjana",
year = "2010",
abstract = "In this paper optimization of chromatographic retention of ramipril and its five impurities employing factorial design is presented. On the basis of preliminary experiments three factors were chosen as inputs (acetonitrile content, pH of the mobile phase and buffer concentration) and retention factor as output. As optimal full factorial design 2(3) was chosen, factors were examined at two different levels "low" and "high". Three replications at zero level were added in order to check linearity and complete statistical tests. Relationship between inputs and output is presented in form of second order interaction model. Adequacy of model was explained using analysis of variance. After analysis of results optimal chromatographic conditions were set. Separations were conducted on a C(18) column with a mixture of acetonitrile and water phase (TEA in potassium dihydrogen phosphate) in ratio 23:77 v/v. Finally, the LC method was validated and applied for quality control analysis of commercially available tablets. The proposed method is simpler and faster as compared to existing official methods and therefore more adequate for routine control of ramipril during shelf life. Also a general approach which includes factorial design in method optimization offers a possibility for predicting and following the chromatographic behavior of such complex mixtures.",
publisher = "Springer Heidelberg, Heidelberg",
journal = "Chromatographia",
title = "Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities",
volume = "71",
number = "9-10",
pages = "799-804",
doi = "10.1365/s10337-010-1546-5"
}
Jančić-Stojanović, B., Popović, I., Malenović, A., Ivanović, D.,& Medenica, M.. (2010). Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities. in Chromatographia
Springer Heidelberg, Heidelberg., 71(9-10), 799-804.
https://doi.org/10.1365/s10337-010-1546-5
Jančić-Stojanović B, Popović I, Malenović A, Ivanović D, Medenica M. Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities. in Chromatographia. 2010;71(9-10):799-804.
doi:10.1365/s10337-010-1546-5 .
Jančić-Stojanović, Biljana, Popović, Igor, Malenović, Anđelija, Ivanović, Darko, Medenica, Mirjana, "Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities" in Chromatographia, 71, no. 9-10 (2010):799-804,
https://doi.org/10.1365/s10337-010-1546-5 . .
3
3
3

Computer-assisted optimization and validation of LC analysis of trimetazidine dihydrochloride and its impurities

Medenica, Mirjana; Ivanović, Darko; Popović, Igor; Malenović, Anđelija; Jančić, Biljana

(Preston Publ Inc, Niles, 2008)

TY  - JOUR
AU  - Medenica, Mirjana
AU  - Ivanović, Darko
AU  - Popović, Igor
AU  - Malenović, Anđelija
AU  - Jančić, Biljana
PY  - 2008
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1075
PB  - Preston Publ Inc, Niles
T2  - Journal of Chromatographic Science
T1  - Computer-assisted optimization and validation of LC analysis of trimetazidine dihydrochloride and its impurities
VL  - 46
IS  - 5
SP  - 430
EP  - 435
DO  - 10.1093/chromsci/46.5.430
ER  - 
@article{
author = "Medenica, Mirjana and Ivanović, Darko and Popović, Igor and Malenović, Anđelija and Jančić, Biljana",
year = "2008",
publisher = "Preston Publ Inc, Niles",
journal = "Journal of Chromatographic Science",
title = "Computer-assisted optimization and validation of LC analysis of trimetazidine dihydrochloride and its impurities",
volume = "46",
number = "5",
pages = "430-435",
doi = "10.1093/chromsci/46.5.430"
}
Medenica, M., Ivanović, D., Popović, I., Malenović, A.,& Jančić, B.. (2008). Computer-assisted optimization and validation of LC analysis of trimetazidine dihydrochloride and its impurities. in Journal of Chromatographic Science
Preston Publ Inc, Niles., 46(5), 430-435.
https://doi.org/10.1093/chromsci/46.5.430
Medenica M, Ivanović D, Popović I, Malenović A, Jančić B. Computer-assisted optimization and validation of LC analysis of trimetazidine dihydrochloride and its impurities. in Journal of Chromatographic Science. 2008;46(5):430-435.
doi:10.1093/chromsci/46.5.430 .
Medenica, Mirjana, Ivanović, Darko, Popović, Igor, Malenović, Anđelija, Jančić, Biljana, "Computer-assisted optimization and validation of LC analysis of trimetazidine dihydrochloride and its impurities" in Journal of Chromatographic Science, 46, no. 5 (2008):430-435,
https://doi.org/10.1093/chromsci/46.5.430 . .
4
6
8

Chromatographic behavior of fosinopril sodium and fosinoprilat using neural networks

Jančić, Biljana; Medenica, Mirjana; Ivanović, Darko; Malenović, Anđelija; Popović, Igor

(Springer Heidelberg, Heidelberg, 2008)

TY  - JOUR
AU  - Jančić, Biljana
AU  - Medenica, Mirjana
AU  - Ivanović, Darko
AU  - Malenović, Anđelija
AU  - Popović, Igor
PY  - 2008
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1070
AB  - In this paper, the chromatographic characterization of fosinopril sodium and fosinoprilat is presented. The first stept was pK(a) determination for the active substance and its degradation product using RP-LC. It was followed by optimization employing the combination of experimental design and artificial neural networks. For the definition of input and output variables, the central composite design for three factors was built. Back propagation algorithm was applied to model the system, and then the optimization of the experimental conditions was carried out in the neural network with 3-8-2 structure, which confirmed to be able to provide the maximum performance. From the method optimization, the most appropriate experimental conditions for fosinopril sodium and fosinoprilat analysis were extracted. The optimized method was validated and applied in the quality control of tablets and for forced degradation studies.
PB  - Springer Heidelberg, Heidelberg
T2  - Chromatographia
T1  - Chromatographic behavior of fosinopril sodium and fosinoprilat using neural networks
VL  - 67
DO  - 10.1365/s10337-008-0575-9
ER  - 
@article{
author = "Jančić, Biljana and Medenica, Mirjana and Ivanović, Darko and Malenović, Anđelija and Popović, Igor",
year = "2008",
abstract = "In this paper, the chromatographic characterization of fosinopril sodium and fosinoprilat is presented. The first stept was pK(a) determination for the active substance and its degradation product using RP-LC. It was followed by optimization employing the combination of experimental design and artificial neural networks. For the definition of input and output variables, the central composite design for three factors was built. Back propagation algorithm was applied to model the system, and then the optimization of the experimental conditions was carried out in the neural network with 3-8-2 structure, which confirmed to be able to provide the maximum performance. From the method optimization, the most appropriate experimental conditions for fosinopril sodium and fosinoprilat analysis were extracted. The optimized method was validated and applied in the quality control of tablets and for forced degradation studies.",
publisher = "Springer Heidelberg, Heidelberg",
journal = "Chromatographia",
title = "Chromatographic behavior of fosinopril sodium and fosinoprilat using neural networks",
volume = "67",
doi = "10.1365/s10337-008-0575-9"
}
Jančić, B., Medenica, M., Ivanović, D., Malenović, A.,& Popović, I.. (2008). Chromatographic behavior of fosinopril sodium and fosinoprilat using neural networks. in Chromatographia
Springer Heidelberg, Heidelberg., 67.
https://doi.org/10.1365/s10337-008-0575-9
Jančić B, Medenica M, Ivanović D, Malenović A, Popović I. Chromatographic behavior of fosinopril sodium and fosinoprilat using neural networks. in Chromatographia. 2008;67.
doi:10.1365/s10337-008-0575-9 .
Jančić, Biljana, Medenica, Mirjana, Ivanović, Darko, Malenović, Anđelija, Popović, Igor, "Chromatographic behavior of fosinopril sodium and fosinoprilat using neural networks" in Chromatographia, 67 (2008),
https://doi.org/10.1365/s10337-008-0575-9 . .
1
2
3

LC determination of lercanidipine and its impurities using DryLab software and experimental design procedures

Popović, Igor; Ivanović, Darko; Medenica, Mirjana; Malenović, Anđelija; Jančić-Stojanović, Biljana

(Vieweg, Wiesbaden, 2008)

TY  - JOUR
AU  - Popović, Igor
AU  - Ivanović, Darko
AU  - Medenica, Mirjana
AU  - Malenović, Anđelija
AU  - Jančić-Stojanović, Biljana
PY  - 2008
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1039
AB  - The main objective in all optimization procedures is to define the most appropriate conditions for rapid, sensitive, precise, and reproducible analysis, as economically as possible. Experimental design and DryLab optimization software have been used to optimize a liquid chromatographic method for separation of lercanidipine and its three impurities. In both methods of optimization the acetonitrile content and pH of the mobile phase were factors extracted for analysis; resolution of a critical pair was output in both cases. Data obtained from both optimization methods were compared and appropriate conclusions were extracted with the objective of gaining a complete view of chromatographic behavior. Detailed description was obtained by use of a three-dimensional graph and DryLab maps. Both methods of optimization reported the most appropriate mobile phase to be a 35:65 mixture of acetonitrile and an aqueous solution of 1.5% TEA, pH adjusted to 3.0 by addition of orthophosphoric acid, at a flow rate 1.0 mL min(-1). Separations were performed on a 20 x 4.6 mm, 3.5-mu m particle size, C-18 column, at 20 degrees C, with UV detection at 240 nm. The method was validated. All the results proved the reliability of the method, so it can be used for separation, identification, and simultaneous determination of these substances in the drug and in pharmaceutical dosage forms.
PB  - Vieweg, Wiesbaden
T2  - Chromatographia
T1  - LC determination of lercanidipine and its impurities using DryLab software and experimental design procedures
VL  - 67
IS  - 5-6
SP  - 449
EP  - 454
DO  - 10.1365/s10337-008-0536-3
ER  - 
@article{
author = "Popović, Igor and Ivanović, Darko and Medenica, Mirjana and Malenović, Anđelija and Jančić-Stojanović, Biljana",
year = "2008",
abstract = "The main objective in all optimization procedures is to define the most appropriate conditions for rapid, sensitive, precise, and reproducible analysis, as economically as possible. Experimental design and DryLab optimization software have been used to optimize a liquid chromatographic method for separation of lercanidipine and its three impurities. In both methods of optimization the acetonitrile content and pH of the mobile phase were factors extracted for analysis; resolution of a critical pair was output in both cases. Data obtained from both optimization methods were compared and appropriate conclusions were extracted with the objective of gaining a complete view of chromatographic behavior. Detailed description was obtained by use of a three-dimensional graph and DryLab maps. Both methods of optimization reported the most appropriate mobile phase to be a 35:65 mixture of acetonitrile and an aqueous solution of 1.5% TEA, pH adjusted to 3.0 by addition of orthophosphoric acid, at a flow rate 1.0 mL min(-1). Separations were performed on a 20 x 4.6 mm, 3.5-mu m particle size, C-18 column, at 20 degrees C, with UV detection at 240 nm. The method was validated. All the results proved the reliability of the method, so it can be used for separation, identification, and simultaneous determination of these substances in the drug and in pharmaceutical dosage forms.",
publisher = "Vieweg, Wiesbaden",
journal = "Chromatographia",
title = "LC determination of lercanidipine and its impurities using DryLab software and experimental design procedures",
volume = "67",
number = "5-6",
pages = "449-454",
doi = "10.1365/s10337-008-0536-3"
}
Popović, I., Ivanović, D., Medenica, M., Malenović, A.,& Jančić-Stojanović, B.. (2008). LC determination of lercanidipine and its impurities using DryLab software and experimental design procedures. in Chromatographia
Vieweg, Wiesbaden., 67(5-6), 449-454.
https://doi.org/10.1365/s10337-008-0536-3
Popović I, Ivanović D, Medenica M, Malenović A, Jančić-Stojanović B. LC determination of lercanidipine and its impurities using DryLab software and experimental design procedures. in Chromatographia. 2008;67(5-6):449-454.
doi:10.1365/s10337-008-0536-3 .
Popović, Igor, Ivanović, Darko, Medenica, Mirjana, Malenović, Anđelija, Jančić-Stojanović, Biljana, "LC determination of lercanidipine and its impurities using DryLab software and experimental design procedures" in Chromatographia, 67, no. 5-6 (2008):449-454,
https://doi.org/10.1365/s10337-008-0536-3 . .
13
13
24

DryLab 2000 Plus® program in HPLC method optimization

Popović, Igor; Ivanović, D.; Medenica, Mirjana; Malenović, Anđelija; Jančić, Biljana

(Savez farmaceutskih udruženja Srbije, Beograd, 2006)

TY  - CONF
AU  - Popović, Igor
AU  - Ivanović, D.
AU  - Medenica, Mirjana
AU  - Malenović, Anđelija
AU  - Jančić, Biljana
PY  - 2006
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/664
PB  - Savez farmaceutskih udruženja Srbije, Beograd
C3  - Arhiv za farmaciju
T1  - DryLab 2000 Plus® program in HPLC method optimization
T1  - Optimizacija HPLC metode primenom DryLab 2000 Plus® programa
VL  - 56
IS  - 5
SP  - 744
EP  - 745
UR  - https://hdl.handle.net/21.15107/rcub_farfar_664
ER  - 
@conference{
author = "Popović, Igor and Ivanović, D. and Medenica, Mirjana and Malenović, Anđelija and Jančić, Biljana",
year = "2006",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "DryLab 2000 Plus® program in HPLC method optimization, Optimizacija HPLC metode primenom DryLab 2000 Plus® programa",
volume = "56",
number = "5",
pages = "744-745",
url = "https://hdl.handle.net/21.15107/rcub_farfar_664"
}
Popović, I., Ivanović, D., Medenica, M., Malenović, A.,& Jančić, B.. (2006). DryLab 2000 Plus® program in HPLC method optimization. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 56(5), 744-745.
https://hdl.handle.net/21.15107/rcub_farfar_664
Popović I, Ivanović D, Medenica M, Malenović A, Jančić B. DryLab 2000 Plus® program in HPLC method optimization. in Arhiv za farmaciju. 2006;56(5):744-745.
https://hdl.handle.net/21.15107/rcub_farfar_664 .
Popović, Igor, Ivanović, D., Medenica, Mirjana, Malenović, Anđelija, Jančić, Biljana, "DryLab 2000 Plus® program in HPLC method optimization" in Arhiv za farmaciju, 56, no. 5 (2006):744-745,
https://hdl.handle.net/21.15107/rcub_farfar_664 .