Articles Accepted

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF RELATED SUBSTANCES AND PURITY OF FAVIPIRAVIR.
by Dr. SHREERANG JOSHI, 27 Oct 2021
Co-Author(s): MANOJ A. MANGUKIYA,Pritam V. Bagwe,Aman A. Desai,Shreerang V. Joshi

A Simple accurate, precise, and reproducible stability-indicating high-performance liquid chromatography (RP-HPLC) method has been developed for the determination of Favipiravir, its known impurities, and degradation products. The method was validated according to the current International Council for Harmonization requirements. The proposed method shows excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria. The calibration plot gave a linear relationship for all known analytes over the concentration range from LOQ to 200 % of specification level. LOD and LOQ for all known analytes were found in the field of 0.02-0.16 µg mL-1 and 0.06-0.40 µg mL-1, respectively. The accuracy of the proposed method was determined by a recovery study. The results of robustness and solution stability studies were within the permissible limits. The developed method is suitable for routine analysis.

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