SIMULTANEOUS SPECTROPHOTOMETRIC DETERMINATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN FIXED DOSE COMBINATION (FDC) BY Q-ABSORBANCE RATIO METHOD

摘要

A simple Q-absorbance ratio method have been developed for the determination of dapagliflozin (DAPA) and saxagliptin (SAXA) in fixed dose combination (FDC) using UV-Visible spectrophotometer. In this method, the UV spectra of DAPA and SAXA were overlaid to obtain wavelength at isosbestic point (A_(iso)) of 217.6 nm and at absorption maximum (A_(max)) of DAPA at 224.2 nm, which are involved in the formation of Q-absorbance equation. Validation of method was done according to ICH guidelines. DAPA and SAXA obeyed Beers law in the concentration range of 2-25 ug/mL and 5-25 ug/mL, respectively. Good accuracy of method was determined by recovery studies and found to be in the range of 103.1-104.6% for DAPA and 97.7-102.4% for SAXA. This method has shown good precision (%RSD < 2.0). Statistical analysis like one-way ANOVA and student t-test were conducted and the reported method was accurate. This method was found to be simple, cheap, eco-friendly accurate and precise and can be used for routine analysis of DAPA and SAXA in FDC for testing regularly in manufacturing units.