A Stability-Indicating HPLC Method to Determine Finasteride in a Tablet Formulation

This document describes a validated HPLC method for determining the amount of finasteride in a tablet formulation. The method was found to be simple, rapid, reproducible, economic, and stability-indicating. The accuracy of the assay was assessed at 80, 100, and 120% of finasteride by recovery experiments, using tablets from the same lot of a commercial formulation. The method was developed by evaluating the effect of mobile phase proportion on retention time and tailing factor, and precision was considered at two levels of ICH suggestions: repeatability and intermediate precision.