Develop and validate a highly sensitive method for the estimation of Molnupiravir in rat plasma by high-performance liquid chromatography-tandem mass spectroscopy and its application to pharmacokinetic studies

Abstract

Utilizing D6-Molnupiravir as a reference standard, a simple, rapid, accurate, effective, and repeatable LC-MS/MS approach was devised for the quantitative measurement of molnupiravir (MNR). The paper reviewed the latest developments in bioanalytical LC-MS/MS techniques employing a 150 x 4.6 mm, 3.5 column used for isocratic elution at ambient temperature. Methanol (MeOH) and acetonitrile (ACN) were employed as the mobile phase at a ratio of 60:40 with a flow rate of 1.0 ml/min. The insertion rate was 10 μl with a runtime of 4 minutes. MNR's retention time was 2.026, and the overall runtime for the separation process was 4.0 min. For MNR, the technique has been tested above a dynamically specified range of 12.50–100 ng/mL with a regression coefficient of 0.999. Outcomes for accuracy, recovery, stability, precision, matrix effect and recovery were reported to fall within acceptable limits. A quick and effective approach for observing the examined sample in bodily fluids was created in pharmacokinetic investigations. The approach indicates that every system suitability parameter, including accuracy, specificity, and linearity, is successfully utilized for pharmacokinetics research in rats and is in excellent accordance with USFDA requirements.