ABSTRACT

A simple, rapid and sensitive validated UV-Spectrophotometry and RP-liquid chromatographic method have been developed for the assay of Molnupiravir in Bulk and Pharmaceutical dosage form. Chromatographic separation achieved on a C18 SpolarG 250×4.6mm column in Isocratic elution with mobile phase containing water methanol, acetonitrile in ratio (75 : 15 : 10 v/v). The flow rate was 1 mL/min and effluents were monitored at 235nm. The elution/retention time of molnupiravir at 6.01 min. LOD and LOQ for HPLC method was 0.125?g/mL and 0.380 ?g/mL respectively. U.V absorption spectra were screened in the range in between 200-400 nm and the assay for molnupiravir absorption set at ? maximum 235nm, the developed method was validated according to ICH guidelines. The linearity data of molnupiravir are2 to 12 ?g/mL, LOD and LOQ are 0.230?g/mL and 0.699?g/mL respectively. The comparative assay studies were performed using UV and liquid chromatography. The developed method was successfully applied to bulk drugs as well as in Pharmaceutical dosage form. Keywords: UV Spectroscopy, RP -HPLC, method development, Molnupiravir
Publication date: 01/07/2023

https://ijbpas.com/pdf/2023/July/MS_IJBPAS_2023_7282.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.7.7282