Stability Indicating Method Development and Validation for Determination of Metformin and Empagliflozin in Bulk and Pharmaceutical Dosage Form by RP-HPLC

https://doi.org/10.54037/WJPS.2022.100108

Authors

  • M. Rohini M. Pharmacy Scholar, Department of Pharmaceutical Analysis, Institute of Science and Technology, JNTUH, Hyderabad
  • M. Ajitha Professor & Head, Deputy Director of Academic Audit Cell - JNTUH & OIE, Center for Pharmaceutical Sciences, JNTUH, Hyderabad

Keywords:

RP-HPLC, Metformin and Empagliflozin, ICH Guidelines

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin and Empagliflozin in Tablet dosage form. Chromatogram was run through Std Symmetry 150 x 4.6 mm, 5m. Mobile phase containing 0.1% OPA Buffer: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 230 nm. Retention time of Metformin and Empagliflozin were found to be 2.276min and 2.890min. %RSD of the Metformin and Empagliflozin were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 100.87% and 100.43% for Metformin and Empagliflozin respectively. LOD, LOQ values obtained from regression equations of Metformin and Empagliflozin were 0.23, 0.75 and 0.01, 0.03 respectively. Regression equation of Metformin is y =27483x + 7407, and y =26728x + 133.3 of Empagliflozin. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

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Published

2022-01-02

How to Cite

M. Rohini, & M. Ajitha. (2022). Stability Indicating Method Development and Validation for Determination of Metformin and Empagliflozin in Bulk and Pharmaceutical Dosage Form by RP-HPLC: https://doi.org/10.54037/WJPS.2022.100108. World Journal of Pharmaceutical Sciences, 10(01), 82–89. Retrieved from http://wjpsonline.com/index.php/wjps/article/view/stability-indicating-development-metformin-empagliflozin-hplc

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Section

Research Article

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