A Validated Stability Indicating High Performance Liquid Chromatographic Method for determination of impurities in Empagliflozin Film Coated Tablets

An entirely new gradient reversed-phase high performance liquid chromatographic technology is used to quantitatively identify empagliflozin and its six process associated contaminants in pharmaceutical dosage forms. With a buffered mobile phase made up of solvent A (orthophosphoric acid 1.0ml diluted with water up to1000mL) and solvent B (a combination of 800:200 v/v ratio of acetonitrile to methanol) delivered with a detection wavelength of 225nm and 1mL/min flow rate, chromatographic separation has been achieved on an Avantor, ACE Excel, 5µm, C18-PFP, 250mm x 4.6 mm. Resolution for every pair of empagliflozin and its six impurities is more than 2.0. The drug was exposed to oxidative, alkaline, hydrolytic, thermal, and photolytic stress conditions. Empagliflozin was observed to deteriorate significantly in the presence of oxidative, acid-base hydrolysis, thermal, and photolytic stress conditions. The method’s stability was demonstrated by the distinct separation of the primary peak, its process-related contaminants, and breakdown products. The mass balance for each degradation sample was found to range from 95% to 105% when the samples kept under stress condition were analysed with respect to a standard reference. Therefore, the detection of empagliflozin by assay in pharmaceutical dose forms is suitable with this method of detection. In accordance with ICH requirements, the developed method’s linearity, specificity, accuracy, precision, limit of detection, and limit of quantification, were all validated.