Bioanalytical method for the simultaneous estimation of atoltivimab, maftivimab and odesivimab in rat plasma by LCMS/MS and its application to a pharmacokinetic study

Ibrahim Baje Syed; Madhavi  Nannapaneni

doi:10.69857/joapr.v12i4.607

Authors

Ibrahim Baje Syed Department of Science and Humanities, Eswar College of Engineering, Kesanupalli Village, Narasaraopet, Palnadu, AP, India
Madhavi Nannapaneni PG Department of Chemistry, JKC College, Andhra Pradesh, Guntur, AP, India

DOI:

https://doi.org/10.69857/joapr.v12i4.607

Keywords:

HPLC-MS/MS, Atoltivimab, Maftivimab, Odesivimab, validation, rat plasma

Abstract

Background: A quick, accurate, reproducible, and straightforward liquid chromatography-tandem mass spectrometry(LC-MS/MS) system employing Atoltavimab, Maftivimab, and Odesivimab as an internal standard for Zanamivir quantification was achieved. Zanamivir is a neuraminidase inhibitor that effectively treats influenza caused by influenza A and B viruses. Methodology: Whenever we use the Kinetex C-18 column, all HPLC parameters and conditions are obeyed, so we use this column. Separation was performed on a Kinetex C18 column (100 mm x 4.6 mm, 2.6µm) using isocratic elution with a buffer containing 1mL of formic acid in 1Lit of water and a mobile step consisting of a 40:60 v/v mixture of two elements, buffer and acetonitrile, with a flow rate of 1mL/min at 30⁰C temperature was used. Results & Discussion: We used different stationary phases in the optimization process, such as C18, C8, and CN-propyl. Using a kinetex C18 column with dimensions of (100 mm x 4.6 mm, 2.6 µm) connected to a PDA detector, we obtain strong peak shapes of Atoltivimab, Maftivimab, and Odesivimab from various trials. Flow rates in the mobile process were set to 1 mL/min. Conclusion: Atoltivimab, Maftivimab, and Odesivimab analysis was completed in 7 minutes over a good linear concentration range of 5ng/mL to 100ng/mL (r² = 0.999), 5ng/mL to 100ng/mL (r² = 0.999), and 5ng/mL to 100ng/mL (r² = 0.9998). The findings of the precision and recovery studies are within the appropriate range.

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References

Jacob ST, Crozier I, Fischer WA, Hewlett A, Kraft CS, Vega MA, Soka MJ, Wahl V, Griffiths A, Bollinger L, Kuhn JH. Ebola virus disease. Nat Rev Dis Primers, 6, 13 (2020).

Leroy EM, Kumulungui B, Pourrut X, Rouquet P, Hassanin A, Yaba P, Délicat A, Paweska JT, Gonzalez JP, Swanepoel R. Fruit bats as reservoirs of Ebola virus. Nature, 438, 575-6 (2005).

Garg R. Inmazeb: new hope for Zaire Ebola virus disease. Int. J.Basic Clin. Pharmacol., 11(3), 285-289, (2022).

Ebola haemorrhagic fever in Zaire, 1976. Bull World Health Organ, 56, 271-93 (1978).

Rao PV, Rao NS, Sahoo BM, Babu NR. Rapid Development and Validation of Atoltivimab, Maftivimab and Odesivimab in Pharmaceutical Dosage form by using the RP-HPLC Method. Current Pharmaceutical Analysis, 20, 212-223 (2024)

Markham A. REGN-EB3: First Approval. Drugs, 81, 175-8 (2021).

Kamorudeen RT, Adedokun KA, Olarinmoye AO. Ebola outbreak in West Africa, 2014 - 2016: Epidemic timeline, differential diagnoses, determining factors, and lessons for future response. J Infect Public Health, 13, 956-62 (2020).

Gupta S, Gupta N, Yadav P, Patil D. Ebola virus outbreak preparedness plan for developing Nations: Lessons learnt from affected countries. J Infect Public Health, 14, 293-305 (2021).

Ganiwada B, Tanuja A, Murthy VSN, Kola PK. Ebola-A review of threatening epidemic. Int. J. Allied Med. Sci. and Clin. Res, 5(2), 517-530 (2017).

Rhymer W, Speare R. Countries' response to WHO's travel recommendations during the 2013-2016 Ebola outbreak. Bull World Health Organ, 95, 10-7 (2017).

Nyenswah TG, Kateh F, Bawo L, Massaquoi M, Gbanyan M, Fallah M, Nagbe TK, Karsor KK, Wesseh CS, Sieh S, Gasasira A, Graaff P, Hensley L, Rosling H, Lo T, Pillai SK, Gupta N, Montgomery JM, Ransom RL, Williams D, Laney AS, Lindblade KA, Slutsker L, Telfer JL, Christie A, Mahoney F, De Cock KM. Ebola and Its Control in Liberia, 2014-2015. Emerg Infect Dis, 22, 169-77 (2016).

Coltart CE, Lindsey B, Ghinai I, Johnson AM, Heymann DL. The Ebola outbreak, 2013-2016: old lessons for new epidemics. Philos Trans R Soc Lond B Biol Sci, 372, 20160297 (2017).

Fasina FO, Shittu A, Lazarus D, Tomori O, Simonsen L, Viboud C, Chowell G. Transmission dynamics and control of Ebola virus disease outbreak in Nigeria, July to September 2014. Euro Surveill, 19, 20920 (2014).

Lu HJ, Qian J, Kargbo D, Zhang XG, Yang F, Hu Y, Sun Y, Cao YX, Deng YQ, Su HX, Dafae F, Sun Y, Wang CY, Nie WM, Bai CQ, Xia ZP, Liu K, Kargbo B, Gao GF, Jiang JF. Ebola Virus Outbreak Investigation, Sierra Leone, September 28-November 11, 2014. Emerg Infect Dis, 21, 1921-7 (2015).

Chevalier MS, Chung W, Smith J, Weil LM, Hughes SM, Joyner SN, Hall E, Srinath D, Ritch J, Thathiah P, Threadgill H, Cervantes D, Lakey DL. Ebola virus disease cluster in the United States--Dallas County, Texas, 2014. MMWR Morb Mortal Wkly Rep, 63, 1087-8 (2014).

Bertoli G, Mannazzu M, Madeddu G, Are R, Muredda A, Babudieri S, Calia G, Lovigu C, Maida I, Contini L, Miscali A, Rubino S, Delogu F, Mura MS. Ebola virus disease: Case management in the Institute of Infectious Diseases, University Hospital of Sassari, Sardinia, Italy. J Infect Dev Ctries, 10, 537-43 (2016).

Bixler SL, Duplantier AJ, Bavari S. Discovering Drugs for the Treatment of Ebola Virus. Curr Treat Options Infect Dis, 9, 299-317 (2017).

Chowell G, Nishiura H. Transmission dynamics and control of Ebola virus disease (EVD): a review. BMC Med, 12, 196 (2014).

Mehedi M, Groseth A, Feldmann H, Ebihara H. Clinical aspects of Marburg hemorrhagic fever. Future Virol, 6, 1091-106 (2011).

Maganga GD, Kapetshi J, Berthet N, Kebela Ilunga B, Kabange F, Mbala Kingebeni P, Mondonge V, Muyembe JJ, Bertherat E, Briand S, Cabore J, Epelboin A, Formenty P, Kobinger G, González-Angulo L, Labouba I, Manuguerra JC, Okwo-Bele JM, Dye C, Leroy EM. Ebola virus disease in the Democratic Republic of Congo. N Engl J Med, 371, 2083-91 (2014).

Kiiza P, Mullin S, Teo K, Adhikari NKJ, Fowler RA. Treatment of Ebola-related critical illness. Intensive Care Med, 46, 285-97 (2020).

Goodman JL. Studying "secret serums"--toward safe, effective Ebola treatments. N Engl J Med, 371, 1086-9 (2014).

Malvy D, McElroy AK, de Clerck H, Günther S, van Griensven J. Ebola virus disease. Lancet, 393, 936-48 (2019).

Muzembo BA, Ntontolo NP, Ngatu NR, Khatiwada J, Suzuki T, Wada K, Kitahara K, Ikeda S, Miyoshi SI. Misconceptions and Rumors about Ebola Virus Disease in Sub-Saharan Africa: A Systematic Review. Int J Environ Res Public Health, 19, 4714 (2022).

Boddington NL, Steinberger S, Pebody RG. Screening at ports of entry for Ebola Virus Disease in England-a descriptive analysis of screening assessment data, 2014-2015. J Public Health (Oxf), 44, 370-7 (2022).

Gupta V, Jain AD, Gill NS, Gupta K. Development and validation of HPLC method-A review. Int. Res. J. Pharm. Appl. Sci., 2(4), 17-25 (2012).

Murin CD, Gilchuk P, Crowe JE, Ward AB. Structural Biology Illuminates Molecular Determinants of Broad Ebolavirus Neutralization by Human Antibodies for Pan-Ebolavirus Therapeutic Development. Front Immunol, 12, 808047 (2021).

Gupta S, Gupta N, Yadav P, Patil D. Ebola virus outbreak preparedness plan for developing Nations: Lessons learnt from affected countries. J Infect Public Health, 14, 293-305 (2021).

Nikolin B, Imamović B, Vuk MS, Sober M. High performance liquid chromatography in pharmaceutical analyses. Bosn.J. Basic Med. Sci., 4(2), 5-9 (2004).

Meher U, Syed IP. Development and validation of stability indicating RP-HPLC method to separate low levels of Atoltivimab, Maftivimab, and Odesivimab and other related compounds. Eur. J. Biomed. Pharm. Sci, 9(9), 77-82 (2022).

Rao PV, Rao NS, Sahoo BM, Babu NR. Rapid Development and Validation of Atoltivimab, Maftivimab and Odesivimab in Pharmaceutical Dosage form by using the RP-HPLC Method. Current Pharmaceutical Analysis, 20, 212 – 223 (2024)

Reddy M, Nimmakayala, Kolli D, Jatla MP. A novel LC-MS/MS method development and validation for the determination of tezepelumab in rat plasma and its application in rat pharmacokinetic studies. Journal of Applied Pharmaceutical Science, 14(06), 154-162 (2024).

Kantipudi R, Kumar S. Bioanalytical method development and validation for the simultaneous estimation of Olanzapine and Samidorphan in rabbit plasma by using HPLC–MS/MS and application to pharmacokinetic study, Future Journal of Pharmaceutical Sciences, 10(1), 1 – 14 (2024).

Dell A, Morris HR. Glycoprotein structure determination by mass spectrometry. Science, 291, 2351-6 (2001).