Abstract

STABILITY INDICATING RP HPLC METHOD DEVELOPMENT FOR ESTIMATION OF FAVIPIRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Patil Aishwarya Balu* and Mahaparale Sonali Paresh

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Abstract

Favipiravir is antiviral drug and nowadays it is part of treatment of covid 19. The aim of the research work was to develop a validated simple, sensitive, precise and specific high performance liquid chromatography method for estimation of favipiravir in bulk and pharmaceutical dosage form. The separation was carried out by using mobile phase consisting Methanol: Water (0.05% Triethylamine) 70:30. C 18 Column used with flow rate 0.8 ml/min.using UV detection at 360 nm. The Calibration curve of Favipiravir in concentration range 20-100 μg/ml. The correlation coefficient (r2 = 0.9997) value indicated clear correlation coefficient between the validated compound concentration and their peak areas within test ranges. The detector response of favipiravir is directly proportional to concentration ranging from 10-100 μg/ml. The repeatability and intermediate precision expressed by % RSD, was less than 2%. The accuracy of method expressed as % recovery was satisfactory (99.7%). The drug was subjected to international conference on harmonization prescribed Hydrolytic, Oxidative, Photolytic and Thermal stress condition. The method was validated according to ICH guidelines. Result Showed that Favipiravir was stable in 0.5 N basic buffer and in 3% oxidative conditions, and some thermal and Photostability conditions, while it was more sensitive towards Acidic degradation. The result of the study showed that the proposed method is simple, rapid, precise, and accurate which is useful for the routine determination of favipiravir in bulk and pharmaceutical dosage form.

Keywords: RP-HPLC, Favipiravir, Forced degradation study, Method development.