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AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities

Authorized Users Only
2017
Authors
Dobričić, Vladimir
Vukadinović, Dragana
Jančić-Stojanović, Biljana
Vladimirov, Sote
Čudina, Olivera
Article (Published version)
Metadata
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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.

Keywords:
LC / AQbD / Design space / Telmisartan / Impurities
Source:
Chromatographia, 2017, 80, 8, 1199-1209
Publisher:
  • Springer Heidelberg, Heidelberg
Funding / projects:
  • Development of molecules with antiinflammatory and cardioprotective activity: structural modifications, modelling, physicochemical characterization and formulation investigations (RS-172041)

DOI: 10.1007/s10337-017-3330-2

ISSN: 0009-5893

WoS: 000406191600006

Scopus: 2-s2.0-85020083635
[ Google Scholar ]
13
7
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3002
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
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 . .

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