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
AuthorMorsy, 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
JournalJournal of Pharmaceutical and Biomedical Analysis
MetadataShow full item record
AbstractA 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/TermsCopyright © 2021 Elsevier B.V. All rights reserved.
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/15396
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