Abstract

Swathi Naraparaju^1*, Karuna Devi Barla¹, Soujanya Chaganti¹, Durga Pani Kumar Anumolu², Krishna Priya Nemani²

DOI : http://dx.doi.org/10.13005/ojc/400306

To determine favipiravir in bulk and marketed formulation, a stability-indicating reversed-phase high performance liquid chromatographic approach has been established that was proved to be sensitive and accurate. SPOLAR C18 column with 250 mm x 4.6 mm, 5 μ dimensions, 0.1% ortho-phosphoric acid buffer: acetonitrile in 50:50 as a mobile phase at 30 °C were used to achieve the chromatographic separation. The retention time of 2.613 min was recorded, when favipiravir measured at 323 nm using 1 mL/min flow rate. The suitable chromatographic conditions were identified through optimization studies. The method showed appreciable linearity (R2 = 0.999) over 10-60 µg/mL concentration range. The calculated values for detection and quantification of favipiravir were 0.12 and 0.37 µg/mL, respectively. The methodology was verified, and the validation parameters results fell within the acceptable range outlined by ICH protocols. Satisfactory result was obtained on adopting optimized protocol in marketed formulation. Hence, this chromatographic methodology is suitable for the regular analysis of favipiravir in various marketed formulations.

Favipiravir; Forced-degradation; High-performance liquid chromatography; Optimization; Validation

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