ABSTRACT

A simple, accurate, isocratic stability indicating RP?HPLC in human plasma method was developed for the determination of Molnupiravir in bulk drug. This RP-HPLC was achieved on “Waters 2695 using an Phenomenex C18 (250mm×4.6mm, 5?m)” column with the mobile phase consisting of Acetonitrile and 0.01 Potassium Dihydrogen phosphate in the ratio of 65:35 %v/v. Quantification of Molnupiravir was based on measuring the peak area at 240 nm. Molnupiravir peak eluted at retention time 3.19 ±0.02 min. The developed HPLC procedure was carefully validated in terms of system suitability, linearity and range, precision, accuracy, specificity, robustness, detection and quantification limits. The suggested approach was validated according to ICH (International Council on Harmonisation) principles, and all of the validation parameters' findings were within acceptable limits. Keywords: Human plasma, Molnupiravir, ICH, Phenomenex
Publication date: 01/10/2023

https://ijbpas.com/pdf/2023/October/MS_IJBPAS_2023_7508.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.10.7508