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Pharmaceutical Chemistry Journal

, Volume 52, Issue 12, pp 1016–1020 | Cite as

HPLC-MS Method for Simultaneous Quantitative Determination of an Innovative Russian Gestagen and its Metabolites in Rat and Rabbit Blood Sera

  • E. S. StepanovaEmail author
  • L. M. Makarenkova
  • V. V. Chistyakov
  • Yu. L. Rybakov
  • V. M. Gukasov
  • T. A. Fedotcheva
  • V. A. Parshin
  • V. A. Votyakov
  • N. L. Shimanovskii
STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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An HPLC-MS method for simultaneous quantitative determination of a novel gestagenic pharmaceutical and two of its metabolites in rat and rabbit blood sera was developed and validated. The method was selective and specific. The detection limit for all analytes was 5 ng/mL; lower limit of quantitation, 10 ng/mL. Calibration curves for all analytes had the form y = ax + b. The correlation coefficients were >0.99. Matrix effects, degree of extraction, and stability of analytes in standard solutions, analytical samples, and the biomatrix with multiple freeze—thaw cycles were studied.

Keywords

gestagens (progestins) gestobutanoyl HPLC-MS validation 

Notes

Acknowledgments

The article was prepared in the framework of State Contract No. 19.12597.2018/12.1, Ministry of Education and Science, Russian Federation, Review of Application Content, Reports, and Results for the State Program “Development of the Pharmaceutical and Medical Industries in 2013 – 2020” and in the framework of existing obligations for the Federal Targeted Program “Development of the Pharmaceutical and Medical Industries of the Russian Federation up to 2020 and Further Prospects.”

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • E. S. Stepanova
    • 1
    Email author
  • L. M. Makarenkova
    • 1
  • V. V. Chistyakov
    • 1
  • Yu. L. Rybakov
    • 2
  • V. M. Gukasov
    • 2
  • T. A. Fedotcheva
    • 3
    • 4
  • V. A. Parshin
    • 3
  • V. A. Votyakov
    • 3
  • N. L. Shimanovskii
    • 3
  1. 1.People’s Friendship University of Russia (RUDN University)MoscowRussia
  2. 2.Scientific Research Institute Federal Research Centre for Project Evaluation and Consulting ServicesMoscowRussia
  3. 3.N. I. Pirogov Russian National Research Medical University, Ministry of Health of the RFMoscowRussia
  4. 4.All-Russia Research Institute of Medicinal and Aromatic Plants (VILAR), Russian Academy of Agricultural SciencesMoscowRussia

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