LIQUID CHROMATOGRAPHY-TANDEM–MASS SPECTROMETRY BIOANALYTICAL TECHNIQUE FOR ESTIMATING FAVIPIRAVIR IN PHARMACEUTICAL DOSE FORMS, BOTH IN BULK AND IN COMBINATION

KIRAN KUMAR GANTA; RAJA SUNDARARAJAN

doi:10.22159/ajpcr.2025v18i11.55789

Authors

KIRAN KUMAR GANTA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM - Deemed to be University, Visakhapatnam, Andhra Pradesh, India.
RAJA SUNDARARAJAN Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM - Deemed to be University, Visakhapatnam, Andhra Pradesh, India.

DOI:

https://doi.org/10.22159/ajpcr.2025v18i11.55789

Keywords:

Liquid chromatography-tandem mass spectrometry, Favipiravir, U.S. Food and Drug Administration (USFDA) guidelines, Mobile phase, Stability

Abstract

Objectives: The aim is to develop a simple, straightforward, quick, and accurate LCMS/MS bioanalytical technique for estimating favipiravir in pharmaceutical dose forms, both in bulk and in combination.

Methods: Phenyl column using an isocratic separation with a 40:60 buffer and acetonitrile combination as the mobile phase and a buffer containing 1 mL of formic acid in 1 L of water.

Results: An excellent linear range of 2 ng/mL to 40 ng/mL (r2=0.9997) was analyzed in the 10-min analysis. Favipiravir shows an LOD of 1 ng/ml (s/n = 4) and an LOQ of 10 ng/ml (s/n = 24). Accuracy, linearity, specificity, precision, system suitability, stability, and recoveries study results are all within the limits.

Conclusion: In accordance with the U.S. Food and Drug Administration criteria, the proposed method was concluded to be suitable for regular evaluation and used for determining the amount of a specific drug component in tablet dosage form. The medicine remained stable during the stability experiments.

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