Determination of Finasteride in Human Plasma by HPLC-MS and Study on the Bioequivalence of Domestic and Imported Finasteride Tablets

    January 2005 in “ Yaowu fenxi zazhi ”
    Jinsong Ding, Rong‐Hua Zhu
    TLDR Domestic and imported finasteride tablets are bioequivalent.
    The study established an HPLC-MS method to determine finasteride levels in plasma and assessed the bioequivalence of domestic and imported finasteride tablets. In a randomized crossover study with 20 healthy volunteers, each received a single 5 mg dose of both tablet types. The results showed that the calibration curve for finasteride was linear, with high recovery rates from plasma and low variability in measurements. The pharmacokinetic parameters, including AUC and C_max, were similar for both tablet types, and the relative bioavailability of domestic to imported tablets was 103.20%±15.08%. The study concluded that there were no significant differences between the two preparations, confirming their bioequivalence. The HPLC-MS method was found to be accurate and sensitive for finasteride determination.
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