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.
Similar content being viewed by others
References
M. Bonn, U. Eydeler, M. Barkworth, and L. C. Rovati, Arzneim. Forsch., 59(12), 651 – 658 (2009).
S. A. Brody, A. Turkes, and J. W. Goldzieher, Contraception, 40, 269 – 284 (1989).
M. L. E. Orme, D. J. Back, and A. M. Breckenridge, Clin. Pharmacokinet., 8, 95 – 136 (1983).
J. W. Goldzieher and S. A. Brody, Am J. Obstet. Gynecol., 163, 2114 – 2119 (1990).
H. M. Beier and K. Beier-Hellwig, Reproduktionsmed. Endokrinol., 1(4), 308 – 317 (2004).
Guidance for Industry: Bioanalytical Method Validation, U. S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U. S. Government Printing Office, Washington, DC (2001).
Guideline on Validation of Bioanalytical Methods, European Medicines Agency, Committee for Medicinal Products for Human Use, London (2009).
E. S. Stepanova, M. V. Ovcharov, S. S. Barsegyan, and V. V. Chistyakov, Khim.-farm. Zh., 50(3), 42 – 46 (2016); Pharm. Chem. J., 50(3), 195 – 199 (2016).
Author information
Authors and Affiliations
Corresponding author
Additional information
Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 51, No. 2, pp. 46 – 56, February, 2017.
Rights and permissions
About this article
Cite this article
Gil’deeva, G.N., Belostotskii, A.V. & Sapozhnikova, D.S. Development and Validation of an HPLC Method with Mass Spectrometric Detection for Quantitative Determination of Chlormadinone Acetate and Ethinyl Estradiol in Human Blood Plasma. Pharm Chem J 51, 142–152 (2017). https://doi.org/10.1007/s11094-017-1573-8
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11094-017-1573-8