Determination of Finasteride in Human Plasma by HPLC-MS

    June 2003 in “ PubMed ”
    Xiang-Yang Li, Li Ding, Li Li, Xin Hao, Zhengxing Zhang
    TLDR The two finasteride formulations are bioequivalent.
    The study aimed to develop an HPLC-MS assay for determining finasteride in human plasma and assess the bioequivalence of two formulations in 20 healthy volunteers. The method involved plasma extraction with ethyl acetate and separation using a C18 column, with LC-ESI-MS performed in SIM mode. Calibration curves were linear from 1-200 micrograms.L-1, with a detection limit of 0.05 microgram.L-1 and recovery rates between 85.9%-98.7%. The analysis showed no significant difference in AUC and Cmax between the formulations, confirming their bioequivalence. The assay was sensitive, accurate, and convenient.
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