A Stability Indicating UPLC Method for Finasteride and Its Related Impurities

January 2012 in “ American Journal of Analytical Chemistry ”

Y. V. Rami Reddy, G.V. Prasad Reddy, K. N. Jaya Veera, Kishore Kumar Hotha

finasteride UPLC impurities alkaline conditions oxidative conditions oxidative hydrolysis Propecia

TLDR A new method effectively analyzes Finasteride and its impurities, even under stress conditions.

The study developed a UPLC method to analyze Finasteride and its impurities in bulk drugs, achieving effective separation with a resolution greater than 2.0. Stress testing showed significant degradation under alkaline and oxidative conditions, with Imp-1 forming during oxidative hydrolysis. The method was validated for various parameters, achieving a mass balance of 99.5% and demonstrated linearity for Finasteride in the range of 2.5-15 μg/mL and impurities in the range of 0.05-3 μg/mL, both with a correlation coefficient of 0.999.

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