Development and Validation of Zero and First-Order Derivative Area under Curve Spectrophotometric Methods for the Determination of Pirfenidone in Bulk Material and Pharmaceutical Formulation

Abstract

The prospective methods explain simple, precise specific and accurate UV spectrophotometry methods for determination of Pirfenidone in bulk and pharmaceutical dosage form. Pirfenidone is a new broad-spectrum anti-fibrotic and anti-inflammatory agent. Four simple methods were established for determination of Pirfenidone by using double beam UV spectrophotometer (UV -2450, Shimadzu, Japan). Pirfenidone shows maximum absorbance (λ max) at 317 nm in methanol as solvent. PFD follows Beer-Lambert's law over the concentration range of 15–40 μg/mL. The % recovery was found to be in the range of 98–102%. Precision value less than 2 in terms of % RSD indicates precise nature of developed methods. Validation of the proposed methods was carried out for its accuracy, precision, specificity and ruggedness according to ICH guidelines. The depicted methods can be routinely be used for determination of PFD in bulk and pharmaceutical formulation.