Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DAPAGLIFLOZIN AND METFORMIN HCl

Khyati J. Patel*, Ankit B. Chaudhary, Shweta M. Bhadani and Ruchi J. Raval

ABSTRACT

A simple, specific, accurate, precise and reproducible and robust method have been developed and validated for the Simultaneous Estimation of Dapagliflozin and Metformin HCl in RP-HPLC Method. The separation was carried out using Inertsil ODS C18 column (250mm x 4.6 mm, 5μ) as stationary phase and UV detector set at 227 nm, in conjunction with a mobile phase of 0.05M Potassium Dihydrogen ortho Phosphate buffer (pH- 3.5, adjusted with 0.1% Orthophosphoric acid) and Acetonitrile in the ratio of 50:50% v/v at a flow rate of 1.0 ml/min. The method is linear over concentration range of 5-15 and 25-75μg/ml for Dapagliflozin and Metformin HCl respectively. The retention time of Dapagliflozin and Metformin HCl were 2.633 min and 5.620 respectively. The % recoveries of Dapagliflozin and Metformin HCl were found to be 100.40%-101.27%, 100.18%-100.63% respectively. Method was statistically validated for accuracy, precision, specificity, LOD, LOQ and robustness according to ICH guidelines. The propose method enables rapid quantification and simultaneous analysis of both the drugs from synthetic mixture without any interference of excipients. So, the method can be used for routine analysis.

Keywords: Dapagliflozin, Metformin HCl, RP-HPLC, Force Degradation, Method Validation.