DEVELOPMENT AND VALIDATION OF A NOVEL RP-HPLC METHOD FOR THE QUANTITATIVE ANALYSIS OF MOLNUPIRAVIR IN BULK AND TABLET DOSAGE FORMS
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ABSTRACT
A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the rapid assay of Molnupiravir in tablet dosage forms. The method employed isocratic elution at a flow rate of 1.0mL/min using a Symmetry C18 column (250 × 4.6 mm, 5 μm particle size) at ambient temperature. The mobile phase is composed of ethanol and Phosphate Buffer pH-4 adjusted with Orthophosphoric acid solution in the ratio of 25:75 (v/v), in an isocratic mode. Detection was carried out at a UV wavelength of 235 nm, with a sample injection volume of 20 μL. The retention time for Molnupiravir was recorded at 4.63 minutes. The precision and accuracy of the method were found to be robust, with a percentage relative standard deviation (RSD) of less than 2%. Validation was performed in accordance with ICH guidelines, confirming the method's reliability. This RP-HPLC method is suitable for routine analysis of Molnupiravir in tablet dosage forms, affirming its effectiveness in quality control applications.
Key words:
Molnupiravir, RP-HPLC, Isocratic elution, ICH guidelines, validated method.
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