Stability Study of Finasteride: Stability-Indicating LC Method, In Silico and LC-ESI-MS Analysis of Major Degradation Product, and an In Vitro Biological Safety Study

    April 2018 in “ Journal of Chromatographic Science ”
    Rafael M. Reis, Fávero Reisdorfer Paula, Michel Mansur Machado, Jonathaline Apollo Duarte, Luís Flávio Souza de Oliveira, Clésio S. Paim, Marcelo Donadel Malesuik
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    Studysummary In this study, researchers found that finasteride undergoes second-order alkaline degradation kinetics and that its degraded form negatively impacts cell proliferation, highlighting the need for careful handling in pharmaceutical manufacturing and storage.
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    This document reports on a stability study of finasteride, a drug used to treat hair loss. The study used a stability-indicating LC method, in silico and LC-ESI-MS analysis of major degradation products, and an in vitro biological safety study. The results showed that the proposed analytical method was precise and accurate, and the quantification of finasteride in tablets was considered robust. The study also included a kinetic analysis of the degradation of finasteride in raw material and tablets solutions submitted to alkaline degradation. Overall, the study provides important information on the stability and safety of finasteride.
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