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

Samo za registrovane korisnike
2017
Autori
Dobričić, Vladimir
Vukadinović, Dragana
Jančić-Stojanović, Biljana
Vladimirov, Sote
Čudina, Olivera
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentu
Apstrakt
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.

Ključne reči:
LC / AQbD / Design space / Telmisartan / Impurities
Izvor:
Chromatographia, 2017, 80, 8, 1199-1209
Izdavač:
  • Springer Heidelberg, Heidelberg
Projekti:
  • Razvoj molekula sa antiinflamatornim i kardioproaktivnim dejstvom: strukturne modifikacije, modelovanje, fizičkohemijska karakterizacija i formulaciona ispitivanja (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
Kolekcije
  • Radovi istraživača / Researchers’ publications
Institucija
Pharmacy

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