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ISSN 2063-5346
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COVID DRUG MOLNUPIRAVIR STABILITY INDICATING UV-VISIBLE SPECTRSCOPIC METHOD DEVELOPMENT AND VALIDATION IN BULK AND PHARMACEUTICAL DOSAGE FORM.

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K.BHAVYA SRI, B.HEMA, DUDDAGI SUCHITRA, ANURADHA MASIPOGU, ANUSHREE HARI, MOGILI SUMAKANTH , VENKATESH KALAPALA
» doi: 10.53555/ecb/2024.13.01.42

Abstract

Molnupiravir is an anti-viral medication used in the treatment of COVID-19. Molnupiravir is the first oral antiviral medication. It acts by increasing the frequency of viral RNA mutations and impairs SARS-CoV-2 replication in humans. There are no known serious side effects with Molnupiravir. The World Health Organization has amended its live recommendations for COVID-19 medicines to add a conditional recommendation for the novel antiviral drug Molnupiravir. The COVID-19 treatment recommendation now has included this medication and has a few safety reports. The WHO suggests active medication safety monitoring in addition to other methods of reducing possible risks. This study aims at method development and validation of Molnupiravir in bulk and dosage form by using UV spectroscopy. ELICO SL-210 UV-Visible spectrometer was used in the study. The diluent used for the determination of Molnupiravir is double distilled water. The absorbance maximum was found to be 236nm. The concentration range is 2µg/ml - 40µg/ml. All the validation parameters were carried out according to ICH Guidelines Q2 (R2) which includes Linearity, Precision, Accuracy; Detection Limit, Quantification Limit, Robustness; Specificity and Range are carried out. The results were found to be within the limits as suggested in the ICH guidelines. Stability studies of Molnupiravir were performed according to ICH Q1A and Q1B guidelines. The tests carried out were acid degradation, alkaline degradation, photolytic degradation, oxidative degradation and thermal degradation. The %degradation of the drug Molnupiravir during the degradation studies was found to be within the limits.

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