DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR ESTIMATION OF MEPHENESIN AND IBUPROFEN

A new RP-HPLC method was developed for Mephenesin (MEP) and Ibuprofen (IBU) and validated as per ICH guidelines. Good chromatographic separation of Mephenesin and Ibuprofen was achieved by using Agilent C-18 column (150mmx4.6mm, 3.2 mu p.s). The system was operated at ambient temperature using a mobile phase consisting of Acetonitrile, 0.01M potassium dihydrogen phosphate pH 3.0 (60: 40 v/v) isocratically at a flow rate of 0.5 ml/min. Detection was carried out at 212 nm and retention time was 3.4 min and 9.3mins respectively. Linearity was achieved from 10-40 mu g/ml for Mephenesin and 2-8 mu g/ml for Ibuprofen with r(2)> 0.99. The analytical method validation studies were performed as per International Conference on Harmonization-Quality (ICH-Q2 (R1)) guidelines. The method was efficiently validated with acceptable accuracy, specificity and precision for the estimation of Mephenesin and ibuprofen. It also aimed to apply the developed and validated method, for the analysis of drug release studies in marketed formulation (gel X) containing Mephenesin and Ibuprofen.