Stability Indicating UPLC Method Development and Validation for Simultaneous Determination of Ertugliflozin and Sitagliptin

Abstract

A selective, robust, economic and short method was developed for the simultaneous estimation of the Ertugliflozin (EGZ) and Sitagliptin (SGP) in Tablet dosage form. Chromatogram was run through X-bridge c18 50 x 2.1 mm, 1.7. Mobile phase containing Buffer: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.01N KH2PO4(3.0PH)buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 240 nm Retention time of EGZ and SGP were found to be 0.883 min and 1.465 min.%RSD of the EGZ and SGP were and found to be 0.3 and 0.8 respectively. %Recovery was obtained as 99.83% and 100.09% for EGZ and SGP respectively. LOD, LOQ values obtained from regression equations of EGZ and SGP were 0.139, 0.421 and 0.18, 0.56 respectively. Regression equation of EGZ is y = 4300x + 253.6, and y = 6814x + 11844 of SGP. 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