Analytical Method Development and Validation of RP-HPLC Method for Estimation of Favipiravir in Bulk and Pharmaceutical dosage form
DOI:
https://doi.org/10.63682/jns.v14i32S.8145Keywords:
Favipiravir, RP-HPLC, Method Validation, ICH Guidelines, Stability-Indicating, Forced DegradationAbstract
Objective: To develop and validate a simple, accurate, and cost-effective RP-HPLC method for the estimation of Favipiravir in bulk and pharmaceutical dosage forms.
Methods: An RP-HPLC method was developed using a C18 column with methanol:water (35:65, v/v) as the mobile phase, pH 3.0, flow rate 0.8 mL/min, and UV detection at 225 nm. The method was validated as per ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, LOD, LOQ, and robustness. Forced degradation studies were conducted as per ICH Q1A(R2).
Results: Favipiravir showed a retention time of 6.62 min. The method was linear over 0.2–3.2 µg/mL with R² > 0.999, LOD: 0.38 µg/mL, and LOQ: 1.15 µg/mL. Recovery ranged between 97.6–100.2% and %RSD was within 0.07–2.80%. Significant degradation occurred only under alkaline stress.
Conclusion: The developed RP-HPLC method is accurate, precise, robust, and stability-indicating. It is suitable for routine analysis and quality control of Favipiravir in pharmaceutical dosage forms
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