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Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach

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Abstract

Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel GF254 as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim.

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Acknowledgements

The authors would like to thank Glenmark Pharmaceuticals, Nashik, India, for providing the gift sample of azilsartan medoxomil and chlorthalidone. The authors would also like to thank the principal, Maliba Pharmacy College, for providing all the required infrastructure and facilities needed to complete this research work.

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Authors and Affiliations

  1. Department of Quality Assurance, Maliba Pharmacy College, Uka Tarsadia University, Tarsadi, Mahuva, Surat, Gujarat, 394350, India

    Pintu Prajapati, Shruti Patel & Ashish Mishra

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  1. Pintu Prajapati
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  2. Shruti Patel
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Correspondence to Pintu Prajapati.

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Prajapati, P., Patel, S. & Mishra, A. Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach. JPC-J Planar Chromat 33, 631–646 (2020). https://doi.org/10.1007/s00764-020-00067-4

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  • DOI: https://doi.org/10.1007/s00764-020-00067-4

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