VALIDATION AND DEVELOPMENT FOR THE ESTIMATION OF PIRFENIDONE IN MARKETED FORMULATION BY RP-HPLC

Abstract

The RP-HPLC method was proved to be simple, precise accurate and sensitive from the results of the validation and it is suitable method for the estimation of pirfenidone in its pharmaceutical dosage forms. A RP-HPLC method was developed using the mobile phase of 50:48.5:1.5 %v/v methanol and water and tri etylamine. The run time of the developed method was six minutes, which reduces the solvent usage. The chromatographic conditions use ambient temperature which can yield accurate, precise results in the range of 25-35 ºC. The results of the validation parameters showed that the method is accurate and precise. Finally, it can be concluded that the methods for quantitation of pirfenidone by RP-HPLC Method in its pharmaceutical dosage forms can be applied for the routine analysis because of simplicity, accuracy, and preciseness