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

    December 2002 in “ Journal of Liquid Chromatography & Related Technologies ”
    Adriana Ines Segall, M. F. Vitale, Victor L. Perez, M. L. Palacios, Maria T. Pizzorno
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    TLDR New method quickly and accurately measures finasteride in tablets.
    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.
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