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


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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.

About the authors

G. N. Gil’deeva

Sechenov First Moscow State Medical University

Email: dsapozhnikova@mail.ru
Russian Federation, Moscow, 128018

A. V. Belostotskii

Sechenov First Moscow State Medical University

Email: dsapozhnikova@mail.ru
Russian Federation, Moscow, 128018

D. S. Sapozhnikova

MDA Ltd.

Author for correspondence.
Email: dsapozhnikova@mail.ru
Russian Federation, Moscow

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