A Validated High-Pressure Liquid Chromatography (HPLC) Method for Molnupiravir

Molnupiravir is an approved antiviral drug that inhibits RNA replication of viruses. It is approved recently (November 2021) for the treatment of infectious diseases caused by SARS-CoV-2. However, it is reported that Molnupiravir is a nucleoside analogue and shown that nucleoside analogues are reagents that resemble the structure of natural nucleosides. It is widely applied in antiviral and anticancer therapy. Therefore, there is a general need appeared for an efficient, fast, simple, and validated analytical assay method for the quantification of this new product in any samples. We report here that an HPLC method was developed, optimized, and validated for molnupravir. The developed method was found to be easy to apply, cheap, and time-saving. Isocratic elution with 10mM Phosphate Buffer pH:7 / Acetonitrile mixture (80:20) with a Phenomenex C18 column was performed and a photodiode array detector was used for the detection. The total time for the analysis was only 10 minutes. The method was found to be selective, linear, accurate, reproducible, and robust. This proposed method can be easily adapted for molnupravir analyses in pharmaceutical products or in any other biological or non-biological samples.