Research Article
MD Irshad Alam, Nazia Khanam,
Abstract
A novel, rapid, specific and stable RP-HPLC assay method was developed and validated for the simultaneous estimation of Dexibuprofen and Paracetamol in tablet dosage form. The separation was carried out by using a mobile phase consisting of Water, Acetonitrile, Methanol and Orthophosphoric acid in the ratio of 300:200:400:1. The column used for separation was Hypersil BDS, C18 (4.6 x 250mm x 5μ) with flow rate of 1.3ml/min and wavelength at 220nm. The retention time for Dexibuprofen and Paracetamol was 10.52 and 2.19 respectively. The stability of the developed method was estimated by stress testing of Dexibuprofen and Paracetamol by exposing them to various forced degradation conditions like acid-base testing, oxidative testing and thermal stress testing. The method was also validated in terms of accuracy, precision, linearity, system suitability, robustness and ruggedness as per ICH guidelines.