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

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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.

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Acknowledgements

This work was financially supported by the Ministry of Education, Science and Technological Development, Republic of Serbia, as part of Project no. 172041.

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Authors and Affiliations

  1. Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, 11000, Serbia

    Vladimir Dobričić, Dragana Vukadinović, Sote Vladimirov & Olivera Čudina

  2. Department of Drug Analysis, Faculty of Pharmacy, University of Belgrade, Belgrade, 11000, Serbia

    Biljana Jančić-Stojanović

Authors
  1. Vladimir Dobričić
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  2. Dragana Vukadinović
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  3. Biljana Jančić-Stojanović
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  4. Sote Vladimirov
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  5. Olivera Čudina
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Corresponding author

Correspondence to Vladimir Dobričić.

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Funding

This study was funded by the Ministry of Education, Science and Technological Development, Republic of Serbia (Grant no. 172041).

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The authors declare that they have no conflict of interest.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Dobričić, V., Vukadinović, D., Jančić-Stojanović, B. et al. AQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impurities. Chromatographia 80, 1199–1209 (2017). https://doi.org/10.1007/s10337-017-3330-2

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