NEW STABILITY INDICATING UPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DAPAGLIFLOZIN AND SAXAGLIPTINAbstract
A new precise, selective, accurate and rapid Ultra Performance Liquid Chromatographic stability indicating method has been developed and validated for simultaneous quantitative determination of Dapagliflozin and Saxagliptin in bulk and pharmaceutical dosage form. The chromatographic separation was achieved with HSS 100 × 2.1 mm, 1.8 m size column. The optimized mobile phase consisting of Phosphate buffer: acetonitrile in the ratio of 50:50 v/v. The flow rate was 0.3 mL/min, and eluents were detected at 260 nm using a PDA detector. The retention time of Dapagliflozin and Saxagliptin were found to be 0.900 and 1.119 min respectively. The percentage recoveries for both the molecules were found to be in the range of 98.61 -100.5%. The calibration curve was constructed between peak areas vs. concentration and demonstrated good linearity in the range of (2.5-15 µg/ml Dapagliflozin and 1.25-7.5 µg/ml Saxagliptin). Degradation studies were carried for Dapagliflozin and Saxagliptin under various stress conditions such as acid, base, oxidation, thermal, photochemical and UV degradation peaks were resolved effectively.
Y. S. Reddy * and D. G. Sankar
Department of Pharmaceutical Analysis, Aditya Pharmacy College, AU Visakhapatnam, Surampalem, Andhra Pradesh, India.
16 October 2018
28 March 2019
03 April 2019
01 July 2019