Fully validated UPLC-MS/MS method for quantifying Favipiravir in human plasma boosted lean six sigma: An application...

Area of Science:

• Analytical Chemistry
• Pharmacokinetics
• Pharmaceutical Science

Background:

• Favipiravir is an antiviral medication requiring precise quantification in biological samples.
• Bioequivalence studies are crucial for generic drug approval and ensuring therapeutic equivalence.
• Robust analytical methods are essential for accurate pharmacokinetic and bioequivalence assessments.

Purpose of the Study:

• To develop and validate a sensitive UPLC-MS/MS method for favipiravir quantification.
• To evaluate the bioequivalence between Favibrivix (test) and Avigan (reference) formulations.
• To ensure the analytical method meets regulatory standards for drug analysis.

Main Methods:

• Developed a UPLC-MS/MS assay using a triple quadrupole mass spectrometer.
• Employed protein precipitation extraction and an Acquity UPLCr BEH HILIC column.
• Validated the method according to US Food and Drug Administration guidelines, assessing linearity, sensitivity, and accuracy.
• Conducted a bioequivalence study in healthy Egyptian participants comparing 200 mg tablet formulations.

Main Results:

• The UPLC-MS/MS method demonstrated high sensitivity and selectivity for favipiravir.
• The assay exhibited a wide linear range (50-10,000 ng/ml) with a high determination coefficient (0.9980).
• Favibrivix 200 mg tablets were found to be statistically bioequivalent to Avigan® 200 mg tablets.

Conclusions:

• The developed UPLC-MS/MS method is suitable for quantifying favipiravir in human matrices.
• Favibrivix is bioequivalent to Avigan, supporting its use as a therapeutic alternative.
• The study provides reliable data for regulatory submission and clinical use of favipiravir formulations.