Author(s):
Radhika Aggarwal, Bhavik Khatter, K. Nagarajan, Pankaj Bhatt
Email(s):
pankajbhattb.pharma@gmail.com
DOI:
10.52711/0974-360X.2025.00354 
Address:
Radhika Aggarwal1, Bhavik Khatter1, K. Nagarajan2, Pankaj Bhatt3*
1Research Scholar, Department of Pharmaceutical Quality Assurance, KIET School of Pharmacy, KIET Groups of Institution, Ghaziabad, Uttar Pradesh, India – 201206.
2KIET School of Pharmacy, KIET Groups of Institution, Ghaziabad, Uttar Pradesh, India – 201206.
3Lloyd Institute of Management and Technology, Plot No. 11, Knowledge Park - II, Greater Noida, Uttar Pradesh 201308.
*Corresponding Author
Published In:
Volume - 18,
Issue - 6,
Year - 2025
ABSTRACT:
A straightforward, sensitive, exact, and approved RP-HPLC a methodology has been developed to analyse Molnupiravir API and for its stability-indicating assay. Molnupiravir exhibits its greatest absorbance at 236nm when measured with a UV/Visible detector. The solvent solution and wavelength were modified to maximize the sensitivity of the proposed method. Using a C18 column that measures 250mm, 4.6mm, and 5m, an HPLC system from Waters 2489 uses acetonitrile and water in a 60:40 ratio. The resilience, linearity, specificity, robustness, and precision of the approach were all validated. For the concentration range of 1–32ug/ml, a mean correlation coefficient of 0.9997 was found, indicating linearity. The suggested method recovered MOL between 99.77% and 100.26%. 1.15µg Ml - 1 and 3.50µg mL-1 were the limits of detection (LOD) and quantification (LOQ), respectively. It was proved that the new RP-HPLC process was precise, accurate, and stable indicating. It is useful in the manufacturing of medications containing APIs. When the strategy was validated using the ICH recommendations and the methodologies given, there were no noticeable differences.
Cite this article:
Radhika Aggarwal, Bhavik Khatter, K. Nagarajan, Pankaj Bhatt. New Analytical Method Development and Validation of Molnupiravir in Bulk and Formulation. Research Journal of Pharmacy and Technology. 2025;18(6):2480-4. doi: 10.52711/0974-360X.2025.00354
Cite(Electronic):
Radhika Aggarwal, Bhavik Khatter, K. Nagarajan, Pankaj Bhatt. New Analytical Method Development and Validation of Molnupiravir in Bulk and Formulation. Research Journal of Pharmacy and Technology. 2025;18(6):2480-4. doi: 10.52711/0974-360X.2025.00354 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-6-7
REFERENCES:
1. https://portal.issn.org/resource/ISSN/2823-2550
2. Features, Evaluation, and Treatment of Coronavirus (COVID-19) - StatPearls - NCBI Bookshelf (nih.gov)
3. Frontiers | Molnupiravir and Its Antiviral Activity Against COVID-19 (frontiersin.org)
4. Molnupiravir: A Versatile Prodrug against SARS-CoV-2 Variants - PMC (nih.gov)
5. 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. Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19. Molecules. 2021; 26(19). doi: https://doi.org/10.3390/molecules26195 795
6. Khiali S, Khani E, S BR, Entezari-Maleki T. Comprehensive review on molnupiravir in COVID-19: a novel promising antiviral to combat the pandemic. Future Microbiol. 2022; 17(5): 377- 391. doi: https://doi.org/10.2217/fmb2021-0252
7. Gider V, Budak C. 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. 2022; 101: 107778. doi: https://doi.org/10.1016/j.compbiolchem.2 022.107778
8. Singla S, Goyal S. Antiviral activity of molnupiravir against COVID-19: a schematic review of evidences. Bull Natl Res Cent. 2022; 46 (1): 62. doi: https://doi.org/10.1186/s42269-022- 00753-9
9. Jain S, Giri S, Sharma N, Shah RP. LC and LC-HRMS studies on stability behavior of molnupiravir an anti-COVID 19 drug. Journal of Liquid Chromatography and Related Technologies. 2022: 1-10. doi: https://doi.org/10.1080/10826076.2022. 2063331
10. Reçber T, Timur SS, Erdoğan Kablan S, Yalçın F, Karabulut TC, Neslihan Gürsoy R, Eroğlu H, Kır S, Nemutlu E. 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. 2022; 214: 114693. doi: https://doi.org/10.1016/j.jpba.2022.1146 93
11. Rele Rajan V., Tiwatane Prathamesh P. Determination of Molnupiravir by Extractive Colorimetric Method from Pharmaceutical Dosage Form. Asian Journal of Research in Chemistry. 2022; 15(4): 256-8.
12. Rele Rajan V., Tiwatane Prathamesh P.. A Validated Potentiometric Titration Method for Quantitative Determination of Molnupiravir from Pharmaceutical Preparation. Asian Journal of Research in Chemistry. 2022; 15(6): 439-2.
13. Rele Rajan V., Tiwatane Prathamesh P. Simple Extractive Spectrophotometric Method for Determination of Molnupiravir from Pharmaceutical Formulation. Asian Journal of Research in Chemistry. 2023; 16(2): 155-8.
14. Akhilesh Gupta, Swati Rawat, Mayuri Gandhi, Jaydeep Singh Yadav. Method Development and Acid Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(1): 10-13.
15. Manoranjan Sabat, Sharada Nalla, Venkateswarlu Goli, Sravan Prasad Macherla, Praveena Kumari Matta, Madhu Chandaka S.. A New Analytical Method Development and Validation for Estimation of Ciprofloxacin in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2012; 2(4): 116-117.
16. Kasad Pinaz A., K.S. Muralikrishna. Method Development and Acid Degradation Study of Rivaroxaban by RP-HPLC in bulk. Asian J. Pharm. Ana. 2013; 3(2): 62-65.
17. Shiv Kumar Gupta, Babita Kumar, Pramod Kumar Sharma. Development and validation of a RP-HPLC method for estimation of Thalidomide in solid dosage form. Asian J. Pharm. Ana. 2013; 3(1): 17-19.
18. K. Vijaya Sri, M. Anusha, S. Ravinder Reddy. A Rapid RP-HPLC Method development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2015; 5(1): 16-20.
19. Prabhu S, Vijay Amirtharaj R, Senthilkumar N. Simultaneous RP-HPLC Method Development and Validation of Cefixime and Ofloxacin in Tablet Dosage Form. Asian J. Research Chem. 2010; 3(2): 367-369.
20. T. Vijayalaxmi, Vunjali Laxman Sai, Ramya Sri. S. HPLC Analytical Method Development and Validation for Estimation of Cytarabine and Daunorubicin in API and Pharmaceutical Formulation. Research Journal of Pharmaceutical Dosage Forms and Technology. 2023; 15(1): 7-3.