STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ERTUGLIFLOZIN AND METFORMIN IN BULK AND PHARMACEUTICAL DOSAGE FORM BY ULTRA PERFORMANCE LIQUID CHROMATOGRAPHYAbstract
A simple, accurate, precise method was developed for the simultaneous estimation of the Ertugliflozin and Metformin in Tablet dosage form. For the method development, Chromatogram was run through HSS C18 (100 × 2.1 mm, 1.7µ) column at a flow rate of 0.3 ml/min. and buffer used in this method was Ortho Phosphoric Acid buffer. The temperature was maintained at 30 °C. The optimized wavelength selected was 240 nm. The retention time of Ertugliflozin and Metformin was found to be 0.736 min and 1.286 min. % RSD of the Ertugliflozin and Metformin were and found to be 0.8 and 0.9 respectively. % Recovery was obtained as 100.98% and 99.81% for Ertugliflozin and Metformin, respectively. LOD, LOQ values obtained from regression equations of Ertugliflozin and Metformin were 0.02 µg/ml, 0.08 µg/ml and 1.04 µ/ml, 3016 µg/ml respectively. The regression equation of validated method for Ertugliflozin is y = 4132.x + 239.4 and y = 3921.x + 4097 of Metformin, respectively. Retention times were decreased so that run time was decreased, the developed method was simple and economical that can be adopted in regular Quality control test in Industries.
V. M. Goud and G. Swapna *
Department of Pharmaceutical Analysis, Joginpally B. R. Pharmacy College, Yenkapally, Moinabad, Ranga Reddy, Hyderabad, Telangana, India.
27 March 2019
02 July 2019
06 November 2019
01 January 2020