DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF EPALRESTAT AND PREGABALIN IN PHARMACEUTICAL DOSAGE FORM

A simple, precise and accurate spectrophotometric method has been developed for the first time to estimate epalrestat and pregabalin present in combined dosage form.Ethanol was used as the solvent for preparing the standard solution.Without prior separation of the analytes, the quantification of epalresta and pregabalin was performed by measuring the absorbance at 390 nm before derivatization and at 575 nm after the derivatization with ninhydrin reagent, respectively.The linearity was established in the range of 5-15 g/mL for both drugs.The method was validated as per ICH guidelines and the results were obtained well within the acceptance limits.It was further applied successfully to the combined tablet dosage form without any interference from the excipients.