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

摘要

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?μm) 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 1.91μg/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