Document Type : Original Article


Department of Pharmaceutical Analysis, Chaitanya Deemed to be University-Pharmacy, Hanamkonda, Warangal-Urban (Dist), Telangana 506001, India


A new simple, selective, rapid, precise reversed-phase high-performance liquid chromatography method has been developed and validated for the estimation of Molnupiravir in bulk and its pharmaceutical dosage form. The separation was made using Symmetry ODS C18 (4.6×150mm, 5µm) column. The mobile phase used contained Methanol. Phosphate Buffer pH-4.2 adjusted with Orthophosphoric acid solution in the ratio of 35:65% v/v in an isocratic mode at a wavelength of 236nm. The mobile-phase flow rate and the sample volume injected were 1 ml/min and 10 μL, respectively. The retention time of Molnupiravir was found to be 2.8 ±0.2mins. A good linear relationship of Molnupiravir r =0.999) was observed over a concentration range of 20 to 100µg/ml of Molnupiravir. The limit of detection (LOD) and limit of quantification (LOQ) for Molnupiravir was found to be 2.6µg/ml and 6.35µg/ml. The recovery percentage was observed in the range of 98-102%. The relative standard deviation for the precision study was found <2%. The developed method is simple, precise, specific, accurate and rapid, making it suitable for the estimation of Molnupiravir in bulk and marketed pharmaceutical dosage form. It was concluded that in the present developed RP- HPLC method is simple, rapid, and accurate, hence can be used for routine quality control analysis in the Pharmaceutical industry.

Graphical Abstract

New analytical method development and validation for estimation of molnupiravir in bulk and tablet dosage form by RP-HPLC method


Main Subjects

Selected author of this article by journal

Prof. Dr. Kumara Swamy Gandla
Chaitanya Deemed to be University-Pharmacy

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  1. Mahase E (2021) Covid-19: Molnupiravir reduces risk of hospital admission or death by 50% in patients at risk, MSD reports. British Medical Journal 375: n2422. doi:
  2. Caraco Y, Crofoot GE, Moncada PA, Galustyan AN, Musungaie DB, Payne B, Kovalchuk E, Gonzalez A, Brown ML, Williams-Diaz A (2022) Phase 2/3 trial of molnupiravir for treatment of Covid-19 in nonhospitalized adults. NEJM Evidence 1 (2): EVIDoa2100043. doi:
  3. Long C, Romero ME, La Rocco D, Yu J (2021) Dissecting nucleotide selectivity in viral RNA polymerases. Computational and Structural Biotechnology Journal 19: 3339-3348. doi:
  4. Zarenezhad E, Marzi M (2022) Review on molnupiravir as a promising oral drug for the treatment of COVID-19. Medicinal Chemistry Research 2022: 1-12. doi:
  5. Rajasekhar S, Das S, Balamurali M, Chanda K (2021) Therapeutic Inhibitory Activities of N‐Hydroxy Derived Cytidines: A Patent Overview. ChemistrySelect 6 (48): 13786-13808. doi:
  6. Amblard F, LeCher JC, De R, Goh SL, Li C, Kasthuri M, Biteau N, Zhou L, Tber Z, Downs-Bowen J (2022) Synthesis of Novel N 4-Hydrocytidine Analogs as Potential Anti-SARS-CoV-2 Agents. Pharmaceuticals 15 (9): 1144. doi:
  7. Hadj Hassine I, Ben M’hadheb M, Menéndez-Arias L (2022) Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity. Viruses 14 (4): 841. doi:
  8. Imran M, Kumar Arora M, Asdaq SMB, Khan SA, Alaqel SI, Alshammari MK, Alshehri MM, Alshrari AS, Mateq Ali A, Al-Shammeri AM, Alhazmi BD, Harshan AA, Alam MT, Abida (2021) Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19. Molecules 26 (19). doi:
  9. Khiali S, Khani E, S BR, Entezari-Maleki T (2022) Comprehensive review on molnupiravir in COVID-19: a novel promising antiviral to combat the pandemic. Future Microbiol 17 (5): 377-391. doi:
  10. Gider V, Budak C (2022) Instruction of molecular structure similarity and scaffolds of drugs under investigation in ebola virus treatment by atom-pair and graph network: A combination of favipiravir and molnupiravir. Computational biology and chemistry 101: 107778. doi:
  11. Singla S, Goyal S (2022) Antiviral activity of molnupiravir against COVID-19: a schematic review of evidences. Bull Natl Res Cent 46 (1): 62. doi:
  12. Jain S, Giri S, Sharma N, Shah RP (2022) LC and LC-HRMS studies on stability behavior of molnupiravir an anti-COVID 19 drug. Journal of Liquid Chromatography & Related Technologies 2022: 1-10. doi:
  13. Reçber T, Timur SS, Erdoğan Kablan S, Yalçın F, Karabulut TC, Neslihan Gürsoy R, Eroğlu H, Kır S, Nemutlu E (2022) A stability indicating RP-HPLC method for determination of the COVID-19 drug molnupiravir applied using nanoformulations in permeability studies. Journal of Pharmaceutical and Biomedical Analysis 214: 114693. doi:
  14. Bindu M, Gandla K, Vemireddy S, Samuel S, Praharsha Y (2022) A validated stability indicating RP-HPLC method for the determination of molnupiravir in pharmaceutical dosage form. World Journal of Advanced Research and Reviews 15 (1): 580-590. doi:
  15. Camlik G, Beyazaslan F, Kara E, Ulker D, Albayrak I, Degim IT (2022) A Validated High-Pressure Liquid Chromatography (HPLC) Method for Molnupiravir. Medical Research Archives 10 (9). doi:
  16. Alosaimi B, Alshanbari HM, Alturaiqy M, AlRawi HZ, Alamri S, Albujaidy A, Bin Sabaan A, Alrashed AA, Alamer A, Alghofaili F (2022) Analyzing the Difference in the Length of Stay (LOS) in Moderate to Severe COVID-19 Patients Receiving Hydroxychloroquine or Favipiravir. Pharmaceuticals 15 (12): 1456. doi:
  17. Raggi MA, Casamenti G, Mandrioli R, Izzo G, Kenndler E (2000) Quantitation of olanzapine in tablets by HPLC, CZE, derivative spectrometry and linear voltammetry. Journal of Pharmaceutical and Biomedical Analysis 23 (6): 973-981. doi:
  18. Chai MK, Tan GH (2009) Validation of a headspace solid-phase microextraction procedure with gas chromatography-electron capture detection of pesticide residues in fruits and vegetables. Food Chemistry 117 (3): 561-567. doi:
  19. Samanidou VF, Ioannou AS, Papadoyannis IN (2004) The use of a monolithic column to improve the simultaneous determination of four cephalosporin antibiotics in pharmaceuticals and body fluids by HPLC after solid phase extraction—a comparison with a conventional reversed-phase silica-based column. Journal of Chromatography B 809 (1): 175-182. doi: