A review on method development and validation of stability indicating RP HPLC Method for metformin and Empagliflozin

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.