METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF PIRFENIDONE IN BULK AND MARKETED FORMULATION AND STUDY OF ITS DEGRADATION BEHAVIOUR BY UV-SPECTROSCOPY

A simple, precise, robust, and stability-indicating UV spectroscopic method was developed for the determination of Pirfenidone in bulk &its formulation, and to monitor the Degradation behaviour of the drug as per ICH Guidelines. Pirfenidone exhibited a maximum absorbance at 311nm in 50 v/v ethanol, which was selected as the analytical wavelength. The calibration curve exhibited a good linear relationship in the concentration range of 4-24µg/ml with a correlation coefficient (r2) of 0.9983. Precision was evaluated through intraday, interday variations with % RSD within 2. The LOD and LOQ were found to be 0.78and 2.41µg/ml respectively. Accuracy was assessed through recovery and was in the range of 98-102%. The mean % assay was found to be 99.81.Degradation studies of Pirfenidone were well studied in all stress conditions, and the amount of degraded drug was calculated(1-3). The degradation products were monitored and characterized to understand the stability profile of Pirfenidone. This validated method can be readily applied for routine quality control analysis of Pirfenidone in bulk and pharmaceutical dosage forms.