Author(s):
Iffath Rizwana, Syed Tabraiz Ullah Hussaini, Javeria Fathima
Email(s):
tabraizullah96@gmail.com
DOI:
10.52711/0974-360X.2026.00044 
Address:
Iffath Rizwana1, Syed Tabraiz Ullah Hussaini2*, Javeria Fathima3
1Professor, Department of Pharmaceutical Analysis and Quality Assurance, Deccan School of Pharmacy, Darussalam, Aghapura, Hyderabad-500001, Telangana, India.
2Assistant Professor, Department of Pharmaceutical Analysis and Quality Assurance, Sultan-Ul-Uloom College of Pharmacy. Mount Pleasant, Banjara Hills Road number 3, Hyderabad-500034, Telangana, India.
3Student of M. Pharmacy, Department of Pharmaceutical Analysis and Quality Assurance, Deccan School of Pharmacy, Darussalam, Aghapura, Hyderabad-500001, Telangana, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 1,
Year - 2026
ABSTRACT:
This study presents a detailed RP-HPLC method for quantifying Atoltivimab (ALT), Maftivimab (MFT), and Odesivimab (ODE) in the Inmazeb injection formulation. Using an Inertsil column and a 50:50 isocratic mobile phase of sodium bisulfate and acetonitrile, the flow rate was maintained at 1.0 ml/min. Detection and quantification were performed simultaneously at 236 nm. Retention times (RT) for ALT, MFT, and ODE were approximately 2.7, 3.9, and 6.2 minutes, respectively, with a linear concentration range of 8.33–25 µg/ml. The Detection limit (LOD) for ALT, MFT, and ODE were 0.050 µg/ml, 0.100 µg/ml, and 0.088 µg/ml, while the limits of quantification (LOQ) were 0.185 µg/ml, 0.333 µg/ml, and 0.293 µg/ml, respectively.
Cite this article:
Iffath Rizwana, Syed Tabraiz Ullah Hussaini, Javeria Fathima. Stability Indicating RP-HPLC Method for Simultaneous Assay of Atoltivimab, Odesivimab and Maftivimab in a Combined Parenteral Dosage form. Research Journal of Pharmacy and Technology. 2026;19(1):308-2. doi: 10.52711/0974-360X.2026.00044
Cite(Electronic):
Iffath Rizwana, Syed Tabraiz Ullah Hussaini, Javeria Fathima. Stability Indicating RP-HPLC Method for Simultaneous Assay of Atoltivimab, Odesivimab and Maftivimab in a Combined Parenteral Dosage form. Research Journal of Pharmacy and Technology. 2026;19(1):308-2. doi: 10.52711/0974-360X.2026.00044 Available on: https://rjptonline.org/AbstractView.aspx?PID=2026-19-1-44
REFERENCES:
1. Ghosh M.K. HPLC methods on drug analysis. Berlin: Springer Verlag. 1992. 1-22.
2. FDA Approved Drug Products: INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection.
3. Day R.A., Underwood AL. Quantitative analysis, 5th ed. New Delhi: Prentice- Hall India Pvt Ltd. 1986. 1-6.
4. Lindsay S. High Performance Liquid Chromatography. 1st ed. New York: Wiley Interscience. 1991. 1-24.
5. Bassett J., Denney R.C., Jeffrey G.H., Mendham J. Vogel’s text Book of Quantitative Inorganic Analysis. 4th ed. England: Longman Group. 1986. 2.
6. Lough W.J., Wainer I.W. High performance liquid chromatography: fundamental principles and practice. Glasgow (UK): Blackie Academic and Professional. 1995. 2-28.
7. Prasad Babu N., Ramachandran D. Development and Validation of Stability Indicating RP-HPLC Method for Quantitative Estimation of Ornidazole and its Impurities in Ornidazole Injection. Research J of Pharm and Tech. 2022; 15(1): 82-88. https://doi.org/10.52711/0974-360X.2022.00015
8. Jacob ST, Crozier I, Fischer WA 2nd, Hewlett A, Kraft CS, Vega MA, Soka MJ, Wahl V, Griffiths A, Bollinger L, Kuhn JH: Ebola virus disease. Nature Reviews Disease Primers. 2020; Feb 20. 6(1). 13. https://doi.org/10.1038/s41572-020-0147-3
9. Saphire EO, Schendel SL, Gunn BM, Milligan JC, Alter G: Antibody-mediated protection against Ebola virus. Nat Immunol. 2018; Nov; 19(11): 1169-1178. https://doi.org/10.1038/s41590-018-0233-9. Epub 2018 Oct 17.
10. Vamseedhar Rayaprolu et al., Structure of the Inmazeb cocktail and resistance to Ebola virus escape. Cell host and microbe. 31. 2023. 260-272. https://doi.org/10.1016/j.chom.2023.01.002
11. Pascal KE, Dudgeon D, Trefry JC, Anantpadma M, Sakurai Y, Murin CD, Turner HL, That Treat Advanced Ebola Virus Disease in Nonhuman Primates. J Infect Dis. 2018 Nov 22. 218 (suppl_5):S612-S626. https://doi.org/10.1093/infdis/jiy285.
12. https://www.ejbps.com/ejbps/abstract_id/9090
13. Soanki, Renu et. al. Development and Validation of Simultaneous Estimation Method for Amoxycillin Trihydrate and Tinidazole in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2013; Vol. 3: Issue 2, Pg 66-71. https://ajpaonline.com/Abstract View.aspx?PID=2013-3-2-8
14. Swapna, Jajow. Madhu, Chandaka. Srivani, Mallepelli. Sumalatha, M. Nehalatha, Y. and Anusha, Y. Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; Vol. 2: Issue 3, Pg 85-89. https://ajpaonline.com/AbstractView.aspx?PID=2012-2-3-6
15. Sebaiy, Mahmoud M. A. Abdullah et. al. Rapid RP-HPLC Method for Simultaneous Estimation of Norfloxacin and Tinidazole in Tablet Dosage Form. Asian J. Pharm. Ana. 2011; Vol. 1: Issue 4, Pg 79-84. https://ajpaonline.com/AbstractView.aspx?PID=2011-1-4-4
16. Eswarudu, M.M. et. al. RP-HPLC Method Development and Validation for Simultaneous Estimation of Irbesartan and Hydrochlorothiazide in Pharmaceutical Dosage Form. Asian J. Research Chem. 5(4): April 2012. https://www.ajrconline.org/AbstractView.aspx?PID=2012-5-4-6
17. Dr. Pant, Shalini et. al. Development and Validation of a Simultaneous HPLC Method for Assay and Dissolution of Bisoprolol fumarate and Amlodipine besylate in Pharmaceutical Dosage. Research J. Ph. Dosage Forms and Tech. 2012; 4(1): 62-663. https://rjpdft.com/AbstractView.aspx?PID=2012-4-1-11
18. Vaishnani, Bhavin. Kimbahune, Ritu. Kabra, Prachi. Surani, Sanjay. Nargund, L.V.G. Validated RP-HPLC Method for Estimation of Rasagiline in Tablet Dosage Form. Asian J. Research Chem. 2012; 5(4). https://www.ajrconline.org/AbstractView.aspx?PID=2012-5-4-14
19. M. M., Maste et. al. Validation and Application of a High-Performance Liquid Chromatography Method for Estimation of Sitagliptin Phosphate from Bulk Drug and Pharmaceutical Formulation. Asian J. R. Chem. 2012; 5(1). https://www.ajrconline.org/AbstractView.aspx?PID=2012-5-1-24
20. Gupta, Akhilesh. Rawat, Swati. Gandhi, Mayuri. And Yadav, Jaydeep Singh. Method Development and Acid Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Ph. Ana. 2011; 1(1); 10-13. https://ajpaonline.com/AbstractView.aspx?PID=2011-1-1-4
21. Gupta, Akhilesh. Yadav, Jaydeep Singh. Rawat, Swati. Gandhi, Mayuri. Method Development and Hydrolytic Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(1): 14-18. https://ajpaonline.com/AbstractView.aspx?PID=2011-1-1-5
22. Fegade Bharti S. et.al., Development and Validation of a Stability indicating RP-HPLC method for Estimation of Deferiprone in its capsule Dosage Form. Research Journal of Pharmacy and Technology. 2024; 17(6). https://doi.org/10.52711/0974-360X.2024.00427
23. Gupta, Akhilesh. Rawat, Swati. Pandey, Arun. Method Development and Photolytic Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(2): 29-33. https://ajpaonline.com/AbstractView.aspx?PID=2011-1-2-3
24. Kasture AV, Mahadik KR, Wadodker SG, More HN. Instrumental methods of Pharmaceutical analysis.Vol-II, 14th ed. Pune: Nirali Prakashan; 2006. 1-30.
25. USP 28, NF 23, The United State Pharmacopoeial Convention: Asian Edition. 2005.
26. Macek Karel et al., Pharmaceutical applications of thin-layer and paper chromatography. Journal of Pharmaceutical Sciences. American Elsevier. 1973.
27. Meyer VR. Practical High Performance Liquid Chromatography. 2nd ed. New York: Wiley Inter Science. 1994. 12.
28. Massart D.L., Vandeginste B.G.M., Deming S.N., Michotte Y., Kaufman L. Chemometrics: A Text Book. Amsterdam: Elsevier Science. 1988. 1-50.
29. Kirkbright G.F. Development and publication of new spectrophotometric methods of analysis. Talanta. 1966. 1-14. https://doi.org/10.1016/0039-9140(66)80119-4
30. Fong G.W, Lam S.K. HPLC in the Pharmaceutical Industry. Vol-47, New York: Marcel Dekker Inc. 1991. 16-56.
31. Zaire Ebolavirus Drugs of Today. 57 (8): 483–490. https://doi.org/10.1358/dot.2021.57.8.3280599 PMID 34405205. S2CID 237198823.
32. Pattengill Merle D., Sands Donald E. Statistical significance of linear least-squares parameters. Journal of Chemical Education. 1979. 56. 4. 244. https://doi.org/10.1021/ed056p244