A NEW VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF METFORMIN HCL AND EMPAGLIFLOZIN IN ITS BULK AND PHARMACEUTICAL DOSAGE FORMS

A New method was established for simultaneous estimation of Metformin and Empagliflozin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Metformin and Empagliflozin by using Symmetry C18 column (4.6×150mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: phosphate buffer (KH₂PO₄ and K₂HPO₄) phosphate pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength used was Waters HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.403 mins and 3.907 mins. The % purity of Metformin and Empagliflozin was found to be 99.87% and 100.27% respectively. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1). The linearity study of Metformin and Empagliflozin was found in concentration range of 50µg-250µg and 5µg-25µg and correlation coefficient (r²) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.3and 0.3, % RSD for intermediate precision was 1.3 and 0.4respectively. LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.