Development and Validation of Stability indicating HPLC method for simultaneous estimation of `Metformin and Ertugliflozin

P. Harsha Hruditha*, Dr. P. Jayachandra Reddy
Krishna Teja Pharmacy College, Renigunta Road, Tirupati, Andhra Pradesh 517506

ABSTRACT
A simple, Accurate, precise method was developed for the simultaneous estimation of the Ertugliflozin and Metformin in Tablet dosage form. Chromatogram was run through phenomenex c18 150 x 4.6 mm, 5m. Mobile phase containing Buffer: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.1% OPA (2.2ph) buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 220.0nm Retention time of Ertugliflozin and Metformin were found to be 2.365 min and 2.868 min. %RSD of the Ertugliflozin and Metformin were and found to be 0.6 and 0.6 respectively. %Recovery was obtained as 100.04% and 99.66% for Ertugliflozin and Metformin respectively. LOD, LOQ values obtained from regression equations of Ertugliflozin and Metformin were 0.34, 1.03 and 0.01, 0.03 respectively. Regression equation of Ertugliflozin is y = 94666x + 1023.and y = 66010x + 12210 of Metformin. 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.
Keywords: Metformin, Ertugliflozin, Mobile phase, Retention time, RP-HPLC