European Journal of Chemistry

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



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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.


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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.

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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.

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