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.
J Pharm Biomed Anal
; 199: 114057, 2021 May 30.
Article
in English
| MEDLINE | ID: covidwho-1164115
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 (50â¯×â¯4.6â¯mm, 3.5⯵m) using a mobile phase composed of methanol-0.2 % acetic acid (2080, v/v) pumped at a flow rate 0.6â¯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 156.00â 113.00 and m/z 124.80â 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 100.0-20000.0â¯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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
SARS-CoV-2
/
COVID-19
Type of study:
Experimental Studies
/
Prognostic study
Limits:
Humans
Country/Region as subject:
Africa
Language:
English
Journal:
J Pharm Biomed Anal
Year:
2021
Document Type:
Article
Affiliation country:
J.jpba.2021.114057
Similar
MEDLINE
...
LILACS
LIS