Cyproterone Acetate Quantification in Human Plasma by High-Performance Liquid Chromatography Coupled to Atmospheric Pressure Photoionization Tandem Mass Spectrometry

    December 2011 in “ Arzneimittelforschung ”
    Ney Carter do Carmo Borges, Ana Cristina Mazuqueli, Ronílson Agnaldo Moreno, Rafael Barrientos Astigarraga, Carlos Sverdloff, Paulo Alexandre Rebelo Galvinas, Mauício Sampaio, Washington Moreira da Silva
    TLDR The method accurately measures cyproterone acetate in plasma, showing no significant difference between two formulations.
    The study developed a specific, fast, and sensitive HPLC-APPI-LC-MS/MS assay for quantifying cyproterone acetate in human plasma, with retention times of 3.26 and 2.90 minutes for cyproterone acetate and its internal standard, finasteride, respectively. The method demonstrated high recovery rates and linear calibration curves within a concentration range of 0.1-50.0 ng/ml, with a lower limit of quantification of 0.1 ng/ml. Precision and accuracy were maintained across various concentrations. The method was applied in a bioequivalence study involving 44 female volunteers, comparing two formulations of cyproterone acetate. Results showed no significant difference in plasma concentration between the test and reference formulations, with geometric mean percent ratios of 90.66% for Cmax and 96.20% for AUC0-t.
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