European Journal of Chemistry

Rapid and sensitive determination of selective progesterone modulator ulipristal acetate in human plasma



Main Article Content

Nagaraju Pappula
Balaji Kodali
Peda Varma Datla

Abstract

Ulipristal acetate is a new synthetic selective progesterone receptor modulator developed mainly as emergency contraceptive (EC) and also used for the treatment of uterine fibroids. A cost effective, sensitive, simple and rapid high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the analysis of ulipristal acetate in human plasma. Following liquid-liquid extraction, the analyte (Ulipristal acetate) and internal standard (Levonorgestrel) were chromatographed using mobile phase in an isocratic elution mode on a reverse phase C18 column. The LC-MS/MS operated in multiple reaction monitoring mode for respective [M+H]+ ions, m/z 476.2/134.1 for analyte and 313.3/245.1 for internal standard. The assay exhibited linear dynamic range of 1-300 ng/mL. The lower limit of quantification was 1 ng/mL with relative standard deviation of 7.0%. The intra-batch and inter-batch results were precise with coefficient variation of 2.7 to 7.0 (%) and accuracy of 94.2-99.8 (%). The validated method was simple, fast and repeatable for bioequivalence, pharmacokinetic and therapeutic monitoring studies.


icon graph This Abstract was viewed 1683 times | icon graph Article PDF downloaded 762 times

How to Cite
(1)
Pappula, N.; Kodali, B.; Datla, P. V. Rapid and Sensitive Determination of Selective Progesterone Modulator Ulipristal Acetate in Human Plasma. Eur. J. Chem. 2017, 8, 258-264.

Article Details

Share
Crossref - Scopus - Google - European PMC
References

[1]. Gemzell-Danielsson, K.; Chun-Xia, M. Int. J. Womens Health. 2010, 2, 53-61.
https://doi.org/10.2147/IJWH.S5865

[2]. Goldstajn, M. S.; Baldani, D. P.; Škrgatić, L.; Radaković, B.; Vrčić, H.; Čanić, T. Collegium Antropol. 2014, 38, 379-384.

[3]. Richardson, A. R.; Fraidy, N. Clin. Ther. 2012, 1, 24-36.
https://doi.org/10.1016/j.clinthera.2011.11.012

[4]. Brache, V.; Cochon, L.; Jesam, C.; Maldonado, R.; Salvatierra, A. M.; Levy, D. P.; Gainer, E.; Croxatto, H. B. Hum. Reprod. 2010, 25, 2256-2263.
https://doi.org/10.1093/humrep/deq157

[5]. Pohl, O.; Zobrist, R. H.; Gotteland, J. P. Reprod. Sci. 2015, 22, 476-483.
https://doi.org/10.1177/1933719114549850

[6]. Jadav, S. P.; Parmar, D. M. J. Pharmacol. Pharmacother. 2012, 3(2), 109-111.

[7]. Shi, J. X.; Zhu, F. Y.; Zou, Q. G.; Sun, L. L; Wei, P. Chin. J. New Drugs 2014, 7, 839-852.

[8]. Pohl, O.; Williams, A. R.; Bergeron, C. B.; Gotteland, J. P. Regul. Toxicol. Pharmacol. 2013, 66, 6-12.
https://doi.org/10.1016/j.yrtph.2013.02.013

[9]. Guidance for Industry: Bioanalytical method validation, U. S. Department of Health and Human services, Food and Drug administration, May 2001, Rockville, MD, USA.

[10]. Bioanalytical method validation guideline, Brazil, Agenda Nacionaldevigilancia Sanitaria (ANVISA) Resolution-RDC no. 27, May 17, 2012.

[11]. Ye, J. H.; Pao, L. H. PLoS One 2014, 24, 1-18.

[12]. Ismaiel, O. A.; Halquist, M. S.; Elmamly, M. Y.; Shalaby, A.; Karnes, H. T. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2007, 859, 84-93.
https://doi.org/10.1016/j.jchromb.2007.09.007

[13]. www.medicines.org.uk/emc/medicine/26068/SPC/#PHARMACOKINETIC_PROPS viewed 05 August 2017.

Supporting Agencies

Most read articles by the same author(s)
TrendMD

Dimensions - Altmetric - scite_ - PlumX

Downloads and views

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
License Terms

License Terms

by-nc

Copyright © 2024 by Authors. This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at https://www.eurjchem.com/index.php/eurjchem/terms and incorporate the Creative Commons Attribution-Non Commercial (CC BY NC) (International, v4.0) License (http://creativecommons.org/licenses/by-nc/4.0). By accessing the work, you hereby accept the Terms. This is an open access article distributed under the terms and conditions of the CC BY NC License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited without any further permission from Atlanta Publishing House LLC (European Journal of Chemistry). No use, distribution, or reproduction is permitted which does not comply with these terms. Permissions for commercial use of this work beyond the scope of the License (https://www.eurjchem.com/index.php/eurjchem/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).