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