A review on method development and validation of stability indicating RP HPLC Method for metformin and Empagliflozin
1 Department of Quality Assurance, Shraddha Institute of Pharmacy, Washim, India.
2 Department of Pharmaceutics, P.Wadhwani College of Pharmacy, Yavatmal, India.
3 Department of Pharmacology, Shraddha Institute of Pharmacy, Washim, India.
4 Department of Pharmaceutical Chemistry, Raosaheb Patil Danve College of Pharmacy, Badnapur, India.
5 Department of Quality Assurance, G. H. Raisoni University School of Pharmacy, Amravati, India.
Review Article
GSC Biological and Pharmaceutical Sciences, 2023, 24(01), 310–318.
Article DOI: 10.30574/gscbps.2023.24.1.0233
Publication history:
Received on 02 May 2023; revised on 13 June 2023; accepted on 16 June 2023
Abstract:
Metformin HCl and empagliflozin are oral antidiabetic medications that help control blood sugar levels. A simple, precise, rapid, accurate, sensitive, specific, and stable RP-HPLC method was developed and validated for the simultaneous determination of Metformin and Empagliflozin in drug bulk form and drug dosage. This new RP-HPLC method is superior to formal reversed-phase HPLC with reduced solvent usage, retention time, resolution, and cost. Upper region separation was performed on a Waters HPLC system equipped with a PDA detector and autosampler. Both Metformin and Empagliflozin undergo stress conditions including acid, alkali, oxidative, thermal, and photodegradation, but significant degradation was observed in acid studies. The newly developed RP HPLC chromatographic method was validated for system compatibility, linearity, robustness, accuracy, and precision.
Keywords:
RP-HPLC; Metformin; Empagliflozin; Stability-indicating method; Tablet dosage form
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Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
