DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE SIMULTANEOUSS ESTIMATION OF PANTOPRAZOLE AND DOMPERIDONE BY UV-SPECTROPHOTOMETRY

A simple, rapid and precise method is developed for the quantitative simultaneous determination of Pantoprazole and Domperidone in combined pharmaceutical-dosage forms. The method was based on UV-Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 290 nm (λmax of Pantoprazole) and 287 nm (λmax of Domperidone) in MeOH:ACN(60:40v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-15 μg/ml for domperidone and 1-50 μg/ml for Pantoprazole respectively, with regression 0.999 and 0.995 for Domperidone and Pantoprazole respectively. Recovery was in the range of 99 -103%; the value of standard deviation and %R.S.D were found to be < 2 %; shows the high precision of the method., in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines.