Determination of Finasteride and Its Pharmacokinetics in Human Plasma by HPLC

    January 2004 in “ Zhongguo yaoke daxue xuebao ”
    Xia Chun
    TLDR Two finasteride preparations are bioequivalent.
    The study established a specific, sensitive, and reproducible HPLC method to analyze the pharmacokinetics and bioavailability of finasteride in human plasma. Using a solid phase extraction procedure and a diamonsil ODS C18 column, finasteride was detected at 215 nm. The study involved 20 volunteers who received a single oral dose of 10 mg of two different finasteride preparations in an open randomized two-way crossover design. The method demonstrated a linear range of 2-128 ng/ml with a limit of determination at 2 ng/ml, a recovery rate of 101.4% ± 2.7%, and an RSD of less than 5%. The pharmacokinetic parameters showed no significant difference between the two preparations, indicating that they were bioequivalent.
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