ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DIPHENHYDRAMINE AND NAPROXEN IN PHARMACEUTICAL DOSAGE FORMS

Abstract

The aim of the present work is to develop a new simple sensitive accurate and economical analytical method and validation for the Simultaneous estimation of Diphenhydramine and Naproxen in pure and pharmaceutical Tablet dosage form by using RP-HPLC and validate the developed method in accordance with ICH guidelines for the intended analytical application i.e., to apply the proposed method for analysis of the drug in its dosage form. And also to apply the developed method for the simultaneous estimation of Diphenhydramine and Naproxen in pure and pharmaceutical tablet dosage form. System (waters 2690 usa), Pump (Analytical HPLC isocratic pump, gradient pump), Detector (waters 996 diode array detector), Software (empower 2 software), Column (Kromosil (250×4.6mm, 5μ) ODS C-18 RP-column), Injector (Rheodyne injector with 20μ capacity), Electronic balance (SHIMADZU electronic balance), Sonicator (Analytical Technologies Limited- Ultrasonic cleaner). Diphenhydramine & Naproxen peaks in the chromatogram passed the system suitability criteria %RSD of peak areas of Diphenhydramine & Naproxen was not more than 2.0% for variation in mobile phase composition. The newly developed RP-HPLC method for determination of Diphenhydramine & Naproxen in tablet dosage forms is specific, precise, accurate and rapid. The proposed method can be conveniently adopted for routine quality control analysis.