title: RP-HPLC and UV Spectrophotometric Methods for Estimation of Pirfenidone in Pharmaceutical Formulations.
abstract: 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 C18 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.
authors.affiliation: Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar-388120, India.
authors.forename: V K
authors.initials: VK
authors.lastname: Parmar
authors.affiliation: Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar-388120, India.
authors.forename: S B
authors.initials: SB
authors.lastname: Desai
authors.affiliation: Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar-388120, India.
authors.forename: T
authors.initials: T
authors.lastname: Vaja
keywords: Pharmaceutical formulation; RP-HPLC; UV; pirfenidone