TY  - JOUR
T1  - A Stability-Indicating HPLC Method for Favipiravir and its Related Substances
AU  - Yazgı, Didem
AU  - Önal, Armağan
PY  - 2025
DA  - September
Y2  - 2025
DO  - 10.26650/IstanbulJPharm.2025.1498494
JF  - İstanbul Journal of Pharmacy
JO  - iujp
PB  - Istanbul University
WT  - DergiPark
SN  - 2587-2087
SP  - 267
EP  - 273
VL  - 55
IS  - 2
LA  - en
AB  - Background and Aims: This study aimed to improve an HPLC method for the quantification of favipiravir (FVP) and its impurities and apply it to a marketed pharmaceutical product.Methods: Chromatographic separations were achieved on a C18 column. The mobile phase comprised 10 mM potassium dihydrogen phosphate buffer (pH 4.0):acetonitrile (90:10 v/v) and acetonitrile in the gradient mode. The peaks were detected at 238 nm and the flow rate was set at 1.5 mL/min. The optimised method has been validated as per the International Conference on Harmonisation (ICH) guidelines Q2 (R1). A sharp peak of FVP was obtained at 5.5 min with no interfering peaks. In addition, the degradation study was conducted under acidic, basic, oxidative, photolytic, and thermal stress conditions.Results: In the calibration curve experiments, the linearity was between 0.5 – 3 μg/mL and r2=0.9985. Recovery ranging from 97.5% to 102.2% for the drug and impurities. The limit of detection (LOD) and limit of quantification (LOQ) concentrations of FVP and its impurities were 0.07 μg/mL and 0.2 μg/mL using s/ n:3, respectively. The precision studies were carried out and the relative standard deviation (RSD) values were found to be between 1.01 and 1.65% and 0.67-1.75% for intra-day precision and inter-day precision; respectively.No degradation peak appeared in the acidic hydrolysis, base hydrolysis, and photolysis stress studies. When the drug was subjected to thermal degradation, impurity B was observed. The degradation of the drug substances was obtained at 0.67% and 1.87% by thermal degradation and oxidation; respectively.Conclusion: The stability-indicating chromatographic methods for the determination of FVP and related components were developed and applied in tablets.
KW  - Favipiravir
KW  - Pharmaceutical preparation
KW  - Stability-indicating
KW  - Validation
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UR  - https://doi.org/10.26650/IstanbulJPharm.2025.1498494
L1  - https://dergipark.org.tr/en/download/article-file/3993792
ER  -