NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DOMPERIDONE AND NAPROXEN IN PHARMACEUTICAL FORMULATION

Abstract

A rapid, precise, accurate, specific and simple RP-HPLC method was developed for simultaneous estimation of Domperidone and Naproxen in its tablet dosage form. A High-performance liquid chromatographySHIMADZU-1700, using Eclipsed pluseC18-(250 X 4.6 mm, i.d, 5 m particle size), with mobile phase composition of Acetonitril: potassium dihydrogen phosphate (40:60) was used. HPLC was calibrated and all parameter were found within the criteria.  Validation performed according to the ICH guidelines. The flow rate was 1.0 ml min-1 and effluent was detected at 289 nm. The retention time of Domperidone and Naproxen were 7.31 and 2.74 min respectively. Linearity was observed over concentration range of 5 – 25 µg mL-1 for Naproxen and 20 - 120 µg mL-1 for Domperidone. In addition to that the other parameter of validation was within the acceptance criteria. Binary mixture and Marketed formulation were successfully analyzed using the developed method