ABSTRACT

Objectives: The present studies outline the structured development and validation of analytical quality by design based reversed-phase high-pressure liquid chromatographic system for estimation of favipiravir that is simple, robust, sensitive, and economical. Methods: The method optimization involved custom design to enhance performance by selecting Solvent composition, column length, run time. Utilizing a Thermo C18, 150×4.6mm, 5?m column in an isocratic elution mode with mobile phase KH2PO4 buffer and methanol, (50:50% v/v) with flow rate 1 ml/min at pH 4.2, detection at 225 nm using a UV/Visible detector, utilization of High-performance liquid chromatography enabled improved drug separation. Results: The use of JMP software was utilized for custom design to screen and optimize critical method parameters. Favipiravir retention time (Rt) was found to be 3.160 minutes. It was discovered that the method's linearity in the range of 50-150 ?g/ml had a r2 of 1. The method LOD and LOQ are computed to be 0.08 ?g/ml and 0.2 ?g/ml, respectively. According to the precision study, there was <2% percentage RSD values found. Recovery was determined to be 100%, verifying the procedure efficacy. Conclusion: The proposed studies utilized analytical quality by design (AQbD) methodology to optimize chromatographic conditions for the routine analysis of Favipiravir. A Favipiravir in bulk form was estimated to be using a RP-HPLC technique, developed and validated and sstability studies were performed according to ICH criterias. Keywords: Coronavirus, Custom Design, RNA polymerase, Influenza, ICH
Publication date: 01/06/2026

https://www.ijbpas.com/pdf/2026/June/MS_IJBPAS_2026_10194.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.6.10194