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Application of Response Surface Methodology for the Development of an Innovative Stability Indicating UHPLC Method for the Simultaneous Determination of Rutin and Catechin in Corn Silk Extract Tablets

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Abstract

The current study highlights the systematic quality by design assisted creation of an efficient analytical technique for the estimation of rutin and catechin in corn silk extract tablets. Quercetin was considered as an internal standard. Response surface methodology in the design of experiments was used for identifying key material attributes and critical process parameters that influence the designated critical analytical attributes. Separation was achieved on the HSS C18 column (100 × 2.1 mm, 1.8 μm). The effects of acetonitrile content (v/v), flow rate, and column temperature on the retention times of the two drugs and their resolution and the number of theoretical plates were investigated and optimized. The optimum chromatographic conditions within the design space were found to be an isocratic mobile phase consisting of buffer and acetonitrile (61.5 : 38.5, v/v) with a flow rate of 0.29 mL/min and a run time of 4 min. The retention times of rutin and catechin were found to be 1.9 and 2.8 min. Different validation parameters were established, and the approach was validated in agreement with the ICH and FDA requirements. Data analysis using statistical methods has revealed that the method is reliable, accurate, and robust.

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ACKNOWLEDGMENTS

The authors thank Akrivis Pharma Research Labs India for providing necessary infrastructure and facilities to carry out this research work.

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Authors and Affiliations

  1. Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), 517502, Tirupati, Andhra Pradesh, India

    Theja Indireddy

  2. Department of Pharmacognosy, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), 517502, Tirupati, Andhra Pradesh, India

    Ramya Kuber

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  1. Theja Indireddy
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Correspondence to Ramya Kuber.

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Indireddy, T., Kuber, R. Application of Response Surface Methodology for the Development of an Innovative Stability Indicating UHPLC Method for the Simultaneous Determination of Rutin and Catechin in Corn Silk Extract Tablets. J Anal Chem 78, 605–621 (2023). https://doi.org/10.1134/S1061934823050088

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  • DOI: https://doi.org/10.1134/S1061934823050088

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