DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF PIRFENIDONE: APPLICATION TO DEGRADATION KINETICS
Harshada S. Patil*, Dr. Sandeep S. Sonawane
ABSTRACT
A simple, precise, and validated stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method was developed for the estimation of pirfenidone. The primary objective was to create a robust method for routine analysis and to study the drug's degradation behavior. On a Thermo Fisher C18 column (250 × 4.6 mm, 5 µm), chromatographic separation was carried out with success using an isocratic mobile phase consisting of acetonitrile: water (40:60 v/v). The wavelength at which the eluent was detected was 317 nm. With a correlation coefficient (r²) of 0.997, the method showed excellent linearity over a concentration range of 5–30 µg/mL. The accuracy was confirmed through recovery studies, which showed results between 98% and 102%, and the precision was established with a %RSD of less than 2%. Forced degradation studies were conducted as per ICH guidelines under acidic, alkaline, thermal, oxidative, and photolytic stress conditions. Pirfenidone showed the highest degradation under alkaline hydrolysis, following first-order kinetics with an activation energy calculated as 37.86 kJ/mol. The specificity of the method was proven, as no interference from degradation products or excipients was seen. The suggested method is robust, accurate, and reliable for quality control and stability testing of pirfenidone in bulk and pharmaceutical dosage forms.
Keywords: RP-HPLC, Stability-Indicating Method, Pirfenidone, Forced Degradation, Method Validation, Kinetics.
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