RP-HPLC and UV spectrophotometric methods for estimation of pirfenidone in pharmaceutical formulations
Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar-388120, India
V. K. Parmar Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT, Changa-388 421 India E-mail: [email protected]
High-performance liquid chromatographic and UV spectrophotometric methods were developed and validated for the quantitative determination of pirfenidone, a novel antifibrotic agent used in idiopathic pulmonary fibrosis. Chromatography was carried out by isocratic technique on a reversed-phase C 18 Zorbax Eclipse plus column with mobile phase consisting of acetonitrile:water (35:65 %v/v) at flow rate of 0.7 ml/min. The UV spectrophotometric determinations were performed at 317 nm using methanol as a solvent. The proposed methods were validated according to International Conference on Harmonization ICH Q2 (R1) guidelines. The linearity range for pirfenidone was 0.2-5.0 and 3-25 µg/ml for HPLC and UV method, respectively. Both the methods were accurate and precise with recoveries in the range of 98 and 102 % and relative standard deviation <2 %. The developed methods were successfully applied for determination of pirfenidone in tablets.