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

Snehal Ganpat Tekawade*, Dr. Ashok Pandurang Pingle, Rina Mohan Sonawane and Rutuja Prabhakar Sonare

ABSTRACT

The new RP-HPLC method was developed and validated for the quantitative determination of Pirfenidone, a novel antifibrotic agent used in idiopathic pulmonary fibrosis. The separation was achieved on GRACE C18 analytical column (250×4.6mm, 5μ) using Methanol: Water (90:10 v/v) as mobile phase with UV-3000-M detector. The flow rate was 0.9 ml/min. The method was validated as per ICH guidelines for precision, linearity, accuracy, robustness. The proposed method was found to be accurate, reproducible & consistent. The standard curve was linear over the concentration range 10-50 μg/ml with r2 close to one (0.999). The % recovery was found to be within 99-100% and relative standard deviation <2%. The developed method was successfully applied for determination of Pirfenidone in the tablet. The simple, less time consuming and cost effective method was developed.

Keywords: RP-HPLC, PIRFENIDONE, VALIDATION, ETC.


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