Validated UV-Spectrophotometric Method for Pirfenidone Estimation in Bulk Drug, Marketed Tablet, and Nanoparticle Formulation

Abstract

The goal of the current research was to create an easy-to-understand, precise, and affordable UV-spectrophotometric method for measuring pirfenidone in bulk, in commercial formulations, and in nanoparticle form. The stock solution of pirfenidone was made using a phosphate buffer with a pH of 7.4, and the highest absorbance wavelength in the absorption spectrum was then identified. The standard curve was developed by preparing various working standard solutions from the aforementioned solution by dilution with the same diluents. This technique was also validated in accordance with International Council for Harmonization (ICH) guidelines. Pirfenidone showed the maximum absorptivity at 311 nm and the linearity range was found to be 10 – 50 μg/mL (R² = 0.998). The limit of detection (LOD) and limit of quantification (LOQ) were 6.1140 μg/mL and 18.527 μg/mL respectively. The validity of all other parameters was determined to be acceptable. It was decided that the precision and accuracy were satisfactory. The developed processes were validated based on ICH standards. All of the validation parameters were found to be acceptable when compared with the standard values. Therefore, the suggested technique for pirfenidone determination in bulk drug and pharmaceutical formulation assays is applicable to everyday activities. The estimation of pirfenidone in pure form, commercial formulations, and nanoparticles was performed using an easy process that did not involve any potentially dangerous chemicals.