Development and validation of molnupiravir assessment in bulk powder and pharmaceutical formulation by the RP-HPLC-UV method

Abstract

An accurate, sensitive and selective RP-HPLC-UV method has been established for the estimation of Molnupiravir (MOL) in pure bulk powder and pharmaceutical formulation. Separation was achieved on an Inertsil C₁₈ column (150.0 mm × 4.6 mm, 5.0 μm), using a mobile phase of 20 mM phosphate buffer pH 2.5 : acetonitrile (80 : 20, v/v%) in isocratic mode with a flow rate of 1.0 mL min⁻¹. The λ_max of MOL prepared in the chosen diluent (ethanol : water in equal proportions) was found to be 230.0 nm. The constructed calibration curve was found to be linear in the concentration range of 0.2–80.0 μg mL⁻¹. The recovery% of MOL using the proposed method was 100.29%. The limit of detection (LOD) and limit of quantification (LOQ) were 0.04 μg mL⁻¹ and 0.12 μg mL⁻¹, respectively. No significant interference was detected in the presence of the common pharmaceutical formulation excipients. The method was validated following the ICH recommendations. All the obtained results were statistically compared with those using reported methods and there were no significant differences. The method developed in this work was successfully employed for the assessment of MOL in bulk powder and pharmaceutical formulation.