An environmentally sustainable RP-HPLC methodology for the quantification of the COVID-19 drug molnupiravir in pure and dosage forms

A comprehensive eco-friendly stability-indicating RP-HPLC method has been developed and validated for the determination of molnupiravir in dosage forms. Molnupiravir quantification was carried out on the Luna C8 column (4.6 mm × 250 mm, 5 µm, 100 Å) from Phenomenex, USA, and set at 25 ℃. The mobile phase consists of water: ethanol (60:40 v/v), at a flow rate of 0.5 mL/min. The injection volume was 20 µL, and detection was implemented at 236 nm. The devised method was validated in accordance with ICH requirements and was discovered to be linear within the range of 0.25-100 µg/mL with a regression coefficient (R2) equal to 0.9999. Molnupiravir was exposed to acidic, basic, oxidative, thermal, and photolytic stress conditions. The accuracy was about 100.69 ± 0.11%, the limits of detection and quantification are 0.0086 and 0.026 µg/mL, respectively, and the intra- and inter-day precision with RSD% did not exceed 1.0%. The total analysis time was less than 7.0 minutes, establishing this method as proper for regular quality control evaluations of molnupiravir. The inclusion of absolute ethanol was required in order to obtain a sufficient resolution. Three methods were used to assess the sustainability. KEY WORDS: Dosage forms, Molnupiravir, RP-HPLC, Stability-indicating, Sustainability Bull. Chem. Soc. Ethiop. 2026, 40(3), 577-592. DOI: https://dx.doi.org/10.4314/bcse.v40i3.7