AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities
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2017
Authors
Dobričić, Vladimir
Vukadinović, Dragana
Jančić-Stojanović, Biljana

Vladimirov, Sote
Čudina, Olivera

Article (Published version)

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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 / ImpuritiesSource:
Chromatographia, 2017, 80, 8, 1199-1209Publisher:
- Springer Heidelberg, Heidelberg
Funding / projects:
DOI: 10.1007/s10337-017-3330-2
ISSN: 0009-5893
WoS: 000406191600006
Scopus: 2-s2.0-85020083635
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PharmacyTY - 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 . .