Development and validation of new analytical method for the simultaneous estimation of ibuprofen and diphenhydramine in bulk and pharmaceutical dosage form by RP-HPLC

Abstract

A simple, accurate, rapid and precise method was developed for the simultaneous estimation of Ibuprofen and Diphenhydramine in Pharmaceutical dosage form. Chromatogram was run through Inertsil ODS (250x4.6mm) 5µ. Mobile phase used was Acetonitrile and Phosphate buffer (45:55) at a flow rate of 1.0 ml/min and detection wavelength was found to be 260 nm. The retention time was found to be 2.32 min and 2.93 min for Ibuprofen and Diphenhydramine respectively. The accuracy and reliability of the method was assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2), accuracy (98-102%), specificity, LOD, LOQ values in accordance with ICH guidelines. The developed method is applicable for routine quality control analysis of selected combined dosage forms.