BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ASCIMINIB ANTICANCER DRUG IN BIOLOGICAL MATRICES BY LC–ESI-MS/MS

MANTRAVADI ANUSHA; KUMAR SHIVA GUBBIYAPPA

doi:10.22159/ijap.2024v16i6.52154

Authors

MANTRAVADI ANUSHA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be Univeristy, Rudraram, Patancheru, Telangana, India https://orcid.org/0009-0008-8533-7222
KUMAR SHIVA GUBBIYAPPA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be Univeristy, Rudraram, Patancheru, Telangana, India

DOI:

https://doi.org/10.22159/ijap.2024v16i6.52154

Keywords:

Asciminib, Cancer, FDA, Sensitivity, Precision, Accuracy

Abstract

Objective: A unique liquid chromatography-mass spectrometry technique is essential for determining the concentration of asciminib in biological matrices, and its development is of the utmost importance.

Methods: The samples that were processed were separated using a Reversed Phase-Phenomenex (100 mm x 4.6 mm, 5 µm) C18 analytical column. The column was equipped with an isocratic moveable phase that consisted of 0.1% (v/v) HCOOH and acetonitrile at a ratio of 18:82% (v/v). The flow rate of the phase was 0.70 ml/min. For asciminib, the multiple reaction monitoring mode was used at m/z 450.23/257.3, while for canagliflozin, it was used at m/z 445.13/267.31.

Results: With a correlation coefficient of 0.9998, the method was linear for asciminib throughout the concentration range of 1.0-2100.00 ng/ml. Each day's accuracy percentage relative standard deviation was within 5.74%. For analytes at the low-quality control level, the mean matrix factors ranged from 96.34 to 104.85% with a % Coefficient of Variance (CV) of 4.21; at the high-quality control level, the range was from 94.62 to 103.88% with a %CV of 3.67.

Conclusion: The method that has been developed has the potential to be used to examine the pharmacokinetics and toxicokinetics of asciminib in various biological samples for both forensic and clinical purposes.

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References

Breccia M, Colafigli G, Scalzulli E, Martelli M. Asciminib: an investigational agent for the treatment of chronic myeloid leukemia. Expert Opin Investig Drugs. 2021;30(8):803-11. doi: 10.1080/13543784.2021.1941863, PMID 34130563.

Jones JK, Thompson EM. Allosteric inhibition of ABL kinases: therapeutic potential in cancer. Mol Cancer Ther. 2020;19(9):1763-9. doi: 10.1158/1535-7163.MCT-20-0069, PMID 32606014.

Schoepfer J, Jahnke W, Berellini G, Buonamici S, Cotesta S, Cowan Jacob SW. Discovery of asciminib (ABL001) an allosteric inhibitor of the tyrosine kinase activity of BCR-ABL1. J Med Chem. 2018;61(18):8120-35. doi: 10.1021/acs.jmedchem.8b01040, PMID 30137981.

Tran P, Hanna I, Eggimann FK, Schoepfer J, Ray T, Zhu B. Disposition of asciminib a potent BCR-ABL1 tyrosine kinase inhibitor in healthy male subjects. Xenobiotica. 2020;50(2):150-69. doi: 10.1080/00498254.2019.1594449, PMID 31006307.

Hou JZ, YE JC, PU JJ, Liu H, Ding W, Zheng H. Novel agents and regimens for hematological malignancies: recent updates from 2020 ASH annual meeting. J Hematol Oncol. 2021;14(1):66. doi: 10.1186/s13045-021-01077-3, PMID 33879198.

Khatri A, Wang J, Pendergast AM. Multifunctional ABL kinases in health and disease. J Cell Sci. 2016;129(1):9-16. doi: 10.1242/jcs.175521, PMID 26729027.

Priya DS, Gubbiyappa, Rangapuram VA. A novel stability indicating reversed phase ultra performance liquid chromatography method for estimation of asciminib its bulk and tablet formulation. Int J Pharm Qual Assur. 2022;13(4):490-5. doi: 10.25258/ijpqa.13.4.23.

Govindarao Y, Ganesh Kumar Y. Drug development and validation of a sensitive bio-analytical LCMS/MS method for quantification of asciminib a chronic myeloid leukemia drug in human plasma. J Drug Alc Res. 2023;12(5):1-15. doi: 10.4303/JDAR/236242.

Lolla S, Gubbiyappa KS, Cheruku S, Bhikshapathi DV. Validation of an LC-MS/MS method for quantitation of fostemsavir in plasma. J Pharmacol Toxicol Methods. 2023 Mar-Apr;120:107254. doi: 10.1016/j.vascn.2023.107254, PMID 36863666.

Bandaru AK, Bomma R, Shankar C, Bhikshapathi DV. Method development validation and application of liquid chromatography electrospray ionization mass spectrometry mass spectrometry method for the quantification of amprenavir in plasma samples. J Appl Pharm Sci. 2022;12(7):115-21. doi: 10.7324/JAPS.2022.120712.

Ravi Y, Bhikshapathi D, Cheruku S, Rajkamal B. Development of fast and simple LC-ESI-MS/MS technique for the quantification of regorafenib; application to pharmacokinetics in healthy rabbits. Curr Pharm Anal. 2021;17(4):554-63. doi: 10.2174/1573412916666191111144707.

FDA guidance for industry. Cent Drug Eval Res Biopharm Bioanal Method Validation; 2001. Available from: http://www.fda.gov/cder/guidance/index.htm.

Sellappan M, Devakumar D. Development and validation of RP-HPLC method for the estimation of escitalopram oxalate and flupentixol dihydrochloride in combined dosage form and plasma. Int J Pharm Pharm Sci. 2021 Feb 1;13(2):61-6. doi: 10.22159/ijpps.2021v13i2.30158.

Gurav P, DamLe M. Bioanalytical method for estimation of teriflunomidein human plasma. Int J Pharm Pharm Sci. 2022 Sep;14(9)19-23. doi: 10.22159/ijpps.2022v14i9.45151.

Janiszewski J, Schneider P, Hoffmaster K, Swyden M, Wells D, Fouda H. Automated sample preparation using membrane microtiter extraction for bioanalytical mass spectrometry. Rapid Commun Mass Spectrom. 1997;11(9):1033-7. doi: 10.1002/(SICI)1097-0231(19970615)11:9<1033::AID-RCM951>3.0.CO;2-5, PMID 9204578.

Puttagunta SB, Shaik RP, Bannoth CK, Challa BS, Awen BZ. Bioanalytical method for quantification of solifenacin in rat plasma by LC-MS/MS and its application to pharmacokinetic study. J Anal Sci Technol. 2014;5(1):35. doi: 10.1186/s40543-014-0035-0.

Cheruku S, Darna B, Medipalli V, Nekkalapudi AR, Sadasivam RK. Bioanalytical method development and validation for the quantitation of larotrectinib in human plasma: application to pharmacokinetics in healthy rabbits. J Appl Pharm Sci. 2023;13(11):111-8. doi: 10.7324/JAPS.2023.127799.

Dadhaniya T, Chaudhary K, Mehta P. Development of LC-MS/MS method for determination of iloperidone in rabbit plasma: application to a pharmacokinetic study. Int J Pharm Pharm Sci. 2013;7(4):294-7.

Zhou J, Gao S, Zhang F, Jiang B, Zhan Q, Cai F. Liquid chromatography tandem mass spectrometry method for simultaneous determination of seven commonly used anticancer drugs in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2012;906:1-8. doi: 10.1016/j.jchromb.2012.07.033, PMID 22959676.

Buszewski B, Noga S. Hydrophilic interaction liquid chromatography (HILIC)-a powerful separation technique. Anal Bioanal Chem. 2012;402(1):231-47. doi: 10.1007/s00216-011-5308-5, PMID 21879300.

Ponnuri RN, Pragallapati P, NR, Mandava VB. A rapid and sensitive liquid chromatography mass spectrometry mass spectrometry method for estimation of pioglitazone keto pioglitazone and hydroxy pioglitazone in human plasma. Asian J Pharm Clin Res. 2017;10(12)120-8. doi: 10.22159/ajpcr.2017.v10i12.20284.

Sura RS, Cvs S, Rachamalla SS. Cvs S, Rachamalla SS. Bioanalytical RP-HPLC method development and validation of clopidogrel bisulfate in wistar rat plasma and its application to pharmacokinetic study. Int J App Pharm. 2022;14(1):106-11. doi: 10.22159/ijap.2022v14i1.43328.