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High Performance Liquid Chromatography/Mass Spectrometry Method for Quantitative Determination of Fludrocortisone in Human Blood Plasma

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

The present work was aimed at the development of an analytical method with high sensitivity, selectivity, and rapidity for pharmacokinetic studies. The new method for quantitative determination of fludrocortisone in human blood plasma employs HPLC and mass spectrometric detection with electrospray ionization (ESI). The deuterium-labeled analog of fludrocortisone (fludrocortisone-D5) was used as the internal standard. The lower limit of quantitation (LLOQ) was 10 pg/mL. The calibration curve was linear in the range 10 – 1000 pg/mL. The coefficient of reliability was at least 0.99. Liquid extraction was used for sample preparation. The proposed technique was tested by studying the bioequivalence of a generic drug in a single administration to healthy volunteers at a dose of 0.1 mg.

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Authors and Affiliations

  1. Mental Health Research Center, 34 Kashirskoe Shosse, Moscow, 115522, Russia

    N. V. Baymeeva, A. I. Platova & I. I. Miroshnichenko

  2. Pharmzashchita Co., 11 Vashutinskoe Shosse, Khimki, Moscow Oblast, 141402, Russia

    A. Yu. Belovolov, V. D. Gladkikh & A. M. Tatarinov

Authors
  1. N. V. Baymeeva
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  2. A. I. Platova
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  3. I. I. Miroshnichenko
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  4. A. Yu. Belovolov
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  5. V. D. Gladkikh
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  6. A. M. Tatarinov
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Corresponding author

Correspondence to N. V. Baymeeva.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 5, pp. 51 – 56, May, 2021.

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Baymeeva, N.V., Platova, A.I., Miroshnichenko, I.I. et al. High Performance Liquid Chromatography/Mass Spectrometry Method for Quantitative Determination of Fludrocortisone in Human Blood Plasma. Pharm Chem J 55, 510–515 (2021). https://doi.org/10.1007/s11094-021-02453-6

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  • DOI: https://doi.org/10.1007/s11094-021-02453-6

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