METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF EMPAGLIFLOZIN IN API

An accurate, precise and rapid RP-HPLC method was developed and subsequently validated for the determination of Empagliflozin in API. Better separation of the drug was achieved on Intersil column(150x40mm, 5 mu m) with the mobile phase consisted of mixture of 0.01 M acetate buffer, methanol in ratio of (30: 70v/v) at flow rate of 2ml/min, with detection at 260nm using PDA detector. The retention time was found to be 1.223min. The method was found to be linear in the range of 2-150ug/ml with a correlation coefficient (r2) of 0.999. The LOD and LOQ of the method were calculated to be 0.7 and 1.91 mu g/ml respectively. The Precision was estimated by employing repeatability; intra-day and inter-day studies and the results were calculated as %RSD values and were found to be within the limits. Recovery of Empagliflozin was found to be in the range of 99.7-100-% which confirms the accuracy of the method. The proposed HPLC method is validated using standard ICH guidelines.