A simple, specific, sensitive, accurate and reliable isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method was developed for the quantitative determination of Pirfenidone in tablet dosage form. Method development was carried out on Welchrom C18 isocratic column (250 mm × 4.6 mm, 5 μm) with Shimadzu LC-20AT Prominence Liquid chromatograph. The mobile phase was a mixture of acetonitrile: water 50:50 v/v, with apparent pH of 3.3, the flow rate was set at 1.0 mL/min and UV detection was made at 315 nm by using UV- spectro photometric detection. Linearity was established for Pirfenidone in the range of 2-10 μg/mL with correlation coefficient 0.999. The retention time of Pirfenidone peak was found at 3.863 minutes. The percentage recovery was found to be 99.60 % to 99.80 % and the % RSD was less than 2%. The developed method was successfully applied for the quantification of bulk and active pharmaceutical ingredient present in Pirfenidone tablet dosage form and the assay content of the drug was found to be 199.821±0.20 mg/tablet. All the results were satisfactory. The proposed method is highly sensitive, precise and accurate and can be successfully applied for the quantitative determination of Pirfenidone in tablet dosage form.
