DEVELOPMENT OF CHROMATOGRAPHIC METHOD AND VALIDATION FOR ESTIMATION OF PIRFENIDONE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

The Pirfenidone (orphan drug) is a novel antifibrotic agent used in idiopathic pulmonary fibrosis. A new RP-HPLC method was developed and validated for the quantitative determination of Pirfenidone in tablet dosage form. Separation was achieved on C18 analytical column (250 × 4.6 mm, 5 $\mu$m) using Acn: Methanol: Water (65:15:20) as mobile phase with PDA detector. $\lambda$ max was found to be at 317 nm. The flow rate was 1ml/min. standard curve was found to be linear over the concentration range of 5-25 $\mu$g/ml with r2 of 0.9989. The % recovery was found to be within 98-100 % and RSD < 2%. The method was validated as per ICH guidelines for linearity, precision, accuracy, robustness. The method was successfully applied for determination of Pirfenidone in tablet dosage form. The develop method was simple, less time consuming and cost effective.