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Author(s): Pathan Najiya Shahnoor*1, Dr. Aejaz Ahmed2, Dr. G. J. Khan.3

Email(s): 1najiyasp@gmail.com

Address: Address Not Available

Published In:   Volume - 2,      Issue - 5,     Year - 2023

DOI: Not Available

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ABSTRACT:
Many countries have approved the use of favipiravir at full dosage in treating SARS-CoV-2 patients in an emergency. The identification of degradation impurities in favipiravir film-coated tablets was accomplished through the development and validation of a precise, accurate, linear, robust, straightforward, and stability-indicating HPLC method. For the purpose of estimating Favipiravir in the active pharmaceutical ingredient and its tablet dosage form using reverse phase high-performance liquid chromatography, forced degradation studies and stability-indicating techniques were developed. The procedure was carried out using a C18 column (250 X 4.6mm X 4µm) and a 60:40 mobile phase mixture of acetonitrile and orthophosphoric acid. The ultra-violet detector was used to maintain the detection wavelength at 324 nm, allowing the mobile phase to pump at a flow rate of 1 ml/min. To establish a stability indicating method, the favipiravir drug was put through a variety of stress situations in accordance with International Conference of Harmonisation Q1A (R2) guidelines. The medication favipiravir was discovered to be susceptible to peroxide breakdown. Mass spectral studies characterised the impurity peak. Analytical standards including linearity, accuracy, precision, sensitivity, and robustness were met during the method's validation. For the estimation of favipiravir, which indicates its stability indicating behaviour, a quick and sensitive method was developed.

Cite this article:
Favipiravir (SARS-CoV-2) degradation impurities: Identification and route of degradation mechanism in the finished solid dosage form using LC/LC-MS method Pathan Najiya Shahnoor*, Dr. Aejaz Ahmed, Dr. G. J. Khan.


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