LC-MS/MS method development and validation for the determination of favipiravir in pure and tablet dosage forms

INTRODUCTION: The analytical method development and validation for the determination of Favipiravir (FVPR) in pure and tablet dosage forms by LC/MS-MS Technique.
METHODS: A simple LC-MS/MS method was developed for the determination of a new antiviral drug, FVPR in pharmaceutical formulations. The stationary phase employed was Shim pack GISS, C18 (100 mm × 2.1 mm, 1.9 μm) column and mobile phase used in pump A was 10.0 mM ammonium acetate and in pump B methanol was used. The gradient program was used with a fixed mobile phase flow rate at 0.4 mLmin-1. The total run time was 5.0 minutes. The proposed method was validated according to the International Conference on Harmonization (ICH) guidelines. The established method found better outcomes.
RESULTS: The linearity graph was found in the range of 50-200 ngmL-1, and the correlation coefficient value (R2) obtained was found to be 1.0. The limit of detection and limit of quantification were 4.044 ngmL-1 and 12.253 ngmL-1, respectively. Tremendous recovery outcomes were observed and found to be 101%, 99.0% and 99.5% for the FVPR at 150% upper, 100% middle and 50% lower concentrations, respectively.
DISCUSSION AND CONCLUSION: All obtained outcomes were complying with the ICH guidelines. The developed method was simple, unique, accurate, robust, precise, and reproducible for the determination of FVPR in tablet formulation. The method is novel and could be adopted in the formulation industry.