Development and Validation of an HPLC Method with Mass Spectrometric Detection for Quantitative Determination of Chlormadinone Acetate and Ethinyl Estradiol in Human Blood Plasma

Abstract

An HPLC method with mass-spectrometric detection was developed for simultaneous quantitative determination of chlormadinone acetate and ethinyl estradiol in human blood plasma. The sample preparation method included liquid—liquid extraction using hexane—Et₂O. The method was validated for selectivity, linearity, accuracy, precision, cross-transfer, and stability. The developed method enabled simultaneous determination of the chlormadinone acetate and ethinyl estradiol blood concentrations in volunteers and could be used for pharmacokinetics studies.