ISSN : 2663-2187

RP-HPLC method development and validation of Molnupiravir in bulk and pharmaceutical dosage form

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Dr.Khagga BhavyaSri, Bhagavathula Hema, DhilliRao Gorja, Dr.Mogli Sumakanth
» doi: 10.48047/AFJBS.6.12.2024.436-449

Abstract

The first antiviral drug taken orally is called molnupiravir, and it is used to treat COVID-19. It inhibits human sars-cov-2 replication by increasing the frequency of viral RNA mutations. This drug has been included to the COVID-19 therapy guideline, and there have been some safety complaints about it. Utilizing RP-HPLC and UV-Visible spectroscopy, simple, precise techniques have been devised for the determination of Molnupiravir in bulk and solid dosage forms. The 200 mg MOBIFLUE tablet dosage form was utilized. The ICH Q2 (R2) recommendations were followed for all validation parameters. An easy-to-use, precise, and accurate RP-HPLC technique was created. The ideal chromatographic conditions were as follows: Phenomenex C18 (150 mm × 4.6 nm, 3μ) for the stationary phase; HPLC grade distilled water (70:30) for the mobile phase, with formic acid added and pH adjusted to 3; the flow rate was kept at 0.4 ml/min; a UV detector with a detection wave length of 236 nm was employed; the column temperature was set at 30 °C; and methanol was used as the diluent. All the results of the validated method were found to be within the limits as specified in the ICH Q2 (R2) Guidelines.

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