Eco-friendly Based UV Spectrophotometric Method and Analytical Quality by Design Aided Stability Indicating RP-HPLC Technique for the Estimation of Molnupiravir

Abstract

Molnupiravir a novel oral broad-spectrum antiviral drug initially developed for the treatment of COVID-19, was quantified using UV spectrophotometric and high-performance liquid chromatographic methods. The linear regression analysis used to build the equations for the multivariate calibration method used the correlation between absorbance and concentration at a set of five different wavelengths. The suggested method can separate Molnupiravir and its breakdown products using a C₁₈ column containing ethanol and phosphate buffer (42.5:57.5% v/v), a flow rate fixed at 0.9 mL/min, and detection done at 235 nm. The suggested techniques were examined and approved in accordance with ICH Q2 (R1) standards. For the UV and HPLC methods, the linearity ranges for molnupiravir were 4-9 and 10-150 g/ml, accuracy, repeatability, and selectivity, with R² values were 0.9999 and 0.9999 with recoveries between 98 and 102% and 2% RSD. The unique strategy was additionally assessed utilising three ways, including additional assessment techniques, such as GAPI, AES, and AGREE, and it was discovered to be environmentally friendly. Based on our findings, developing new pharmaceutical drugs may benefit from using UV and HPLC procedures with Green Analytical Performances using the Quality by Design methodology to assess drug stability.

GRAPHICAL ABSTRACT

Keywords:

• Anti-Viral
• Degradation
• Green Analytical Quality by Design
• HPLC
• UV-Spectro-photometry
• Evaluation