Volume : 13, Issue : 09, September – 2026
Title:
A NEW ANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF NIRMATRELVIR AND RITONAVIR IN BULK FORM AND PHARMACEUTICAL DOSAGE FORM
Authors :
G. Vijaya Kumar*, B. Sravanthi, Gaini Pavan
Abstract :
A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for simultaneous determination of Nirmatrelvir and Ritonavir in pure form and marketed combined pharmaceutical dosage forms. A column having Symmetry (C18) (150mm x 4.6mm, 5µm) in isocratic mode with mobile phase containing Methanol: Phosphate Buffer (pH-3.8) (28:72v/v) was used. The flow rate was 1.0 ml/min and effluent was monitored at 252 nm. The retention time (min) and linearity range (ppm) for Nirmatrelvir and Ritonavir were (1.788, 3.475min) and (10-30, 10-50), respectively. The method has been validated for linearity, accuracy and precision, robustness and limit of detection and limit of quantitation. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.86µg/ml and 2.58µg/ml for Nirmatrelvir and 1.28µg/ml 3.84µg/ml for Ritonavir respectively. The developed method was found to be accurate, precise and selective for simultaneous determination of Nirmatrelvir and Ritonavir in tablets.
Keywords: Nirmatrelvir and Ritonavir, RP-HPLC, Validation, Accuracy, Precision.
Cite This Article:
Please cite this article in press G. Vijaya Kumar et al., A New Analytical Rp-Hplc Method Development And Validation For The Simultaneous Determination Of Nirmatrelvir And Ritonavir In Bulk Form And Pharmaceutical Dosage Form.,. Indo Am. J. P. Sci, 2026; 13(09).
REFERENCES:
1. https://go.drugbank.com/drugs/DB16691
2. https://pubchem.ncbi.nlm.nih.gov/compound/Nirmatrelvir
3. https://en.wikipedia.org/wiki/Nirmatrelvir
4. https://go.drugbank.com/drugs/DB00503
5. https://pubchem.ncbi.nlm.nih.gov/compound/Ritonavir
6. https://en.wikipedia.org/wiki/Ritonavir
7. Instrumental Methods of Chemical Analysis by B.K. Sharma, pp.75-78, 113-115.
8. Instrumental Methods of Chemical Analysis, Vth Ed., by Galen W. Ewing, 1.
9. Pharmaceutical Analysis, 1st edition, by Takeru Higuchi, Einar Brochmann, Hanffen Hanssen, 1-10.
10. Practical Pharmaceutical Chemistry, IV edition, Volume II, by A.H. Beckett, J.B. Stenlake, 275-298.
11. Quality assurance, worth the effort, Inforum, october2003 volume 7; Number.4.
12. Quantitative Analysis of drugs in Pharmaceutical formulation, IIIrd Ed., by P.D. Sethi, pp.1-21, 51-56.
13. Kasture et al, Hand book of Pharmaceutical Analysis, Volume-1.Shetti.P.D, High Performance Liquid Chromatography, 2001, P.11.
14. Validation of Analytical Procedures, Methodology, and ICH Harmonized Tripartite Guidelines, 1996.
15. Text on Validation of Analytical Procedures, ICH Harmonized Tripartite Guidelines, 1994.
16. Ravi Shankar, a Text book of Pharmaceutical Analysis, Third edition, page 2.2.
17. Shethi PD. HPLC- Quantitative analysis of pharmaceutical formulations. 1st Ed. New Delhi: CBS Publishers & Distributors; 2001: 8-10, 101-103.
18. Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pharmaceutical Analysis: Vol-II. 8th Ed. Pune: Nirali Prakashan; 2002: 48-57.
19. Prajapati GA. Method development and validation for simultaneous estimation of Hypertensive drugs by RP-HPLC. M.Pharm Thesis, Maliba Pharmacy College, Gujarat Technological University, Gujarat, India, 2011: 7-28.
20. Gabor S. HPLC in pharmaceutical Analysis: Vol. I. 1st Ed. London: CRC Press; 1990:101-173.
21. Jeffery GH, Bassett J. Vogel’s textbook of Quantitative Chemical Analysis. 5th Ed. New York: John Wiley & Sons Inc; 1991: 217-235.
22. Hobart HW, Merritt LL, John AD., Instrumental Methods of Analysis. 7th Ed. New Delhi: CBS Publishers; 1988: 580-610.
23. Sharma BK., Instrumental Method of Chemical Analysis. 20th Ed. Meerut: Goel Publishing House; 2001: 54-83.
24. Ashutoshkar. Pharmaceutical Drug Analysis. 2nd Ed. New Delhi: New Age International Publisher; 2005: 455-466.
25. Ahuja S, Michael WD. Hand book of Pharmaceutical Analysis by HPLC. 1st Ed. London: Elsevier Academic Press; 2005: 44-54.
26. Snyder LR, Kirkland JL, Glajch JL. Practical HPLC Method Development. 3rd Ed. New York: Wiley; 1988: 227.
27. Skoog DA, West DM. Principles of Instrumental Analysis. 2nd Ed. Saunders Golden Sunburst Series. Philadelphia; 1980: 674-675, 690-696.
28. Snyder LR, Kirkland JL, Glajch JL. Practical HPLC Method Development. 2nd Ed. New York: Wiley; 1997: 1-19.
29. Valko K, Snyder LR, Glajch J. Retention in Reversed-Phase Liquid Chromatography as a function of mobile phase composition. J. Chromatogr. A. 1993; 656(2): 501-520.
30. Neue UD. HPLC Columns: Theory, Technology and Practice. 2nd Ed. New York: John Wiley & Sons; 1997: 174-186.
31. Kazakevich Y, Lobrutto R. HPLC for Pharmaceutical Scientists. 1st Ed. New Jersey: John Wiley & Sons Inc; 2007: 987-1051.
32. A. Venkata Suresh Babu1*, H. K Sharma2, Method Development and Validation of Ritonavir and Nirmatrelvir in Tablet Dosage Form by Using Rp-High Performance Liquid Chromatography, Eur. Chem. Bull. 2023, 12(Special Issue 5), 815 – 825.
33. S. Pallavi, G. Sowjanya, Development and validation of a new RP-UPLC method for the simultaneous estimation of Nirmatrelvir and ritonavir in bulk and copacked tablet dosage forms, Research Journal of Pharmacy and Technology 2023; 16(9):4370-6. Doi: 10.52711/0974-360X.2023.00715.
34. David Blessing Rani J1,2*, Asha Deepti C1, Development of a Simple Accurate Method, Validation and It’s Degradation Studies of Nirmatrelvir, Ritonavir in Bulk and Marketed Formulation by RP-HPLC, IJPQA, Volume 14 Issue 3, July – September 2023, pages: 740-744.




