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

Само за регистроване кориснике
2017
Аутори
Dobričić, Vladimir
Vukadinović, Dragana
Jančić-Stojanović, Biljana
Vladimirov, Sote
Čudina, Olivera
Чланак у часопису (Објављена верзија)
Метаподаци
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Апстракт
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.

Кључне речи:
LC / AQbD / Design space / Telmisartan / Impurities
Извор:
Chromatographia, 2017, 80, 8, 1199-1209
Издавач:
  • Springer Heidelberg, Heidelberg
Пројекти:
  • Развој молекула са антиинфламаторним и кардиопроактивним дејством: структурне модификације, моделовање, физичкохемијска карактеризација и формулациона испитивања (RS-172041)

DOI: 10.1007/s10337-017-3330-2

ISSN: 0009-5893

WoS: 000406191600006

Scopus: 2-s2.0-85020083635
[ Google Scholar ]
7
6
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/3002
Колекције
  • Radovi istraživača / Researchers’ publications
Институција
Pharmacy

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