Simple Green Spectrophotometric & Chromatographic Assay of the Oral Antiviral Treatment of COVID -19: Molnupiravir -EIDD-2801

Abdel Moneim, Mona; Kamal, Miranda; Hamdy, Mohamed

doi:10.21608/ejchem.2022.135659.5976

Simple Green Spectrophotometric & Chromatographic Assay of the Oral Antiviral Treatment of COVID -19: Molnupiravir -EIDD-2801

Document Type : Original Article

Authors

¹ Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Pharos University in Alexandria, Alexandria, Egypt.

² Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Beheira, Egypt.

10.21608/ejchem.2022.135659.5976

Abstract

Although vaccination for “Coronavirus disease 2019” is currently available, effective antiviral therapy is of great importance. The presence of easily administrated oral antivirals was a goal since beginning of the pandemic. The end of 2021 witnessed the emergency use authorization to Merck oral antiviral drug Molnupiravir (MOL). This study presents three analytical procedures to assay MOL in its raw material and dosage form. Method I: direct spectrophotometric measuring at λmax 233 nm using methanol as a solvent. Method II: HPTLC method, using methanol and glacial acetic acid as mobile phase followed by densitometric scanning of MOL bands at its λmax. Method III: RP-HPLC-DAD procedure, where MOL is separated only in 5 minutes, using isocratic elution of acetonitrile and distilled water acidified with orthophosphoric acid (pH 3) with ratio 87:13 (flow rate 1 mL/min.). The DAD detection was done also at 233 nm. These methods were validated to be ready for MOL rapid quality control assay in its fast massive production with good linearity correlation coefficients in ranges of 2.5-20 μg/mL, 0.03-0.38 μg/band and 0.025-10 μg/mL, for methods I, II & III, respectively. Limits of detections of 0.53 μg/mL, 0.01 μg/band & 0.005 μg/mL of methods I, II & III, respectively show the proposed methods’ sensitivity. In addition, the three methods were applied for assaying MOL in laboratory prepared capsules to prove the methods’ selectivity. Finally, the greenness of the three proposed methods was assessed & compared to those of the previously reported methods for MOL single assay by AGREE metric for greenness assessment.

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