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    A novel LC-MS/MS method for determination of the potential antiviral candidate favipiravir for the emergency treatment of SARS-CoV-2 virus in human plasma: Application to a bioequivalence study in Egyptian human volunteers

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    Author
    Morsy, Mosaad I
    Nouman, Eman G
    Abdallah, Youmna M
    Zainelabdeen, Mourd A
    Darwish, Mohamed M
    Hassan, Ahmed Y
    Gouda, Amira S
    Rezk, Mamdouh R
    Abdel-Megied, Ahmed M
    Marzouk, Hoda M
    Date
    2021-04-01
    Journal
    Journal of Pharmaceutical and Biomedical Analysis
    Publisher
    Elsevier B.V.
    Type
    Article
    
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    See at
    https://doi.org/10.1016/j.jpba.2021.114057
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8015396/
    Abstract
    A novel, fast and sensitive LC-MS/MS method was developed and validated for the bioanalysis of the antiviral agent favipiravir (FAV); a promising candidate for treatment of SARS-CoV-2 (COVID-19) in human plasma using pyrazinamide as an internal standard (IS). Simple protein precipitation was adopted for plasma sample preparation using methanol. Chromatographic separation was accomplished on Eclipse plus C18 column (50 × 4.6 mm, 3.5 μm) using a mobile phase composed of methanol-0.2 % acetic acid (20:80, v/v) pumped at a flow rate 0.6 mL/min in an isocratic elution mode. The API4500 triple quadrupole tandem mass spectrometer was operated with multiple-reaction monitoring (MRM) in negative electrospray ionization interface for FAV and positive for IS. The MRM function was used for quantification, with the transitions set at m/z 156.00→ 113.00 and m/z 124.80→ 81.00 for FAV and IS. The method was optimized and fully validated in accordance to US-FDA guidelines. Linearity was acquired over a concentration range of 100.0-20000.0 ng/mL by computing using weighted linear regression strategy (1/x2). The proposed method was effectively applied for the pharmacokinetic evaluation of FAV and to demonstrate the bioequivalence of a new FAV formulation (test) and reference product in healthy Egyptian human volunteers.
    Rights/Terms
    Copyright © 2021 Elsevier B.V. All rights reserved.
    Keyword
    Bioequivalence study
    COVID-19
    Favipiravir
    Human plasma
    LC–MS/MS
    SARS-CoV-2
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/15396
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.jpba.2021.114057
    Scopus Count
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    UMB Open Access Articles
    UMB Coronavirus Publications

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