AN LC-ESI-MS/MS METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF INFIGRATINIB IN BIOLOGICAL MATRICES
DOI:
https://doi.org/10.22159/ijap.2024v16i1.49476Keywords:
Infigratinib, Cholangiocarcinoma, LC-MS/MS, Validation, LinearityAbstract
Objective: The study was aimed to develop a precise and simple liquid chromatographic electrospray ionization tandem mass spectrometric (LC-ESI-MSMS) technique is essential for the quantification of Infigratinib in biological matrices.
Methods: Chromatographic resolution was attained with PhenominexC18 (50 mm×2.6 mm, 3 µm) stationary column and a mobile solvent composition of 0.1% HCOOH, methyl alcohol and acetonitrile in the proportion of 10:10:80. Chromatograms were resolved by an isocratic separation with a flowing rate of 0.50 ml/min at 40 °C.
Results: Quantitation was executed by monitoring the transitions of m/z. 560.19/189.13 for Infigratinib and 494.5→394.5 for Imatinib internal standard in multiple reaction monitoring. The standard curve regression line was y = 0.0016x+0.0062 and the correction coefficient (r2) was 0.9994. The % CV outcomes for matrix effect at Lower-QC and Higher-QC were 4.95% and 3.61% respectively. The percentage average recoveries for Infigratinib in Higher-QC (900ng/ml), MQC (600ng/ml) and Lower-QC (3ng/ml) were 93.27%, 94.69% and 97.24% respectively. The intra and interday precisions of analytical procedure was estimated by assessing the %CV outcomes and were in between 1.88 to 5.93% for the QC samples.
Conclusion: The developed procedure can be useful for the assessment of Infigratinib in biological matrices in quality control, forensic and bioavailability studies.
Downloads
References
Botrus G, Raman P, Oliver T, Bekaii Saab T. Infigratinib (BGJ398): an investigational agent for the treatment of FGFR-altered intrahepatic cholangiocarcinoma. Expert Opin Investig Drugs. 2021;30(4):309-16. doi: 10.1080/13543784.2021.1864320, PMID 33307867.
Blechacz B. Cholangiocarcinoma: current knowledge and new developments. Gut Liver. 2017;11(1):13-26. doi: 10.5009/gnl15568, PMID 27928095.
Lima NC, Atkinson E, Bunney TD, Katan M, Huang PH. Targeting the Src pathway enhances the efficacy of selective FGFR inhibitors in urothelial cancers with FGFR3 alterations. Int J Mol Sci. 2020;21(9):3214. doi: 10.3390/ijms21093214, PMID 32370101.
Kang C. Correction to: infigratinib: first approval. Drugs Drugs. 2022;82(1):93. doi: 10.1007/s40265-021-01652-5, PMID 34817843.
Roskoski R Jr. Properties of FDA-approved small molecule protein kinase inhibitors: a 2022 update. Pharmacol Res. 2022;175:106037. doi: 10.1016/j.phrs.2021.106037.
Attwa MW, AlRabiah H, Mostafa GAE, Kadi AA. Development of an LC-MS/MS method for quantification of sapitinib in human liver microsomes: in silico and in vitro metabolic stability evaluation. Molecules. 2023;28(5):2322. doi: 10.3390/molecules28052322, PMID 36903565.
Xu Xuegu, Chen C, Liu YN, Meng X, Cai Jp, Xu RA. Establishment and validation of a UPLC-MS/MS bioassay for the quantification of infigratinib in rat plasma. Arab J Chem. 2022;15(7):103893. doi: 10.1016/j.arabjc.2022.103893.
Allard M, Khoudour N, Rousseau B, Joly C, Costentin C, Blanchet B. Simultaneous analysis of regorafenib and sorafenib and three of their metabolites in human plasma using LC-MS/MS. J Pharm Biomed Anal. 2017;142:42-8. doi: 10.1016/j.jpba.2017.04.053, PMID 28494338.
Moola KS, Challa BSR, Bannoth CK. Quantification of tolvaptan in rabbit plasma by LC-MS/MS: application to a pharmacokinetic study. J Pharm Anal. 2015;5(6):371-7. doi: 10.1016/j.jpha.2014.09.001, PMID 29403951.
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.
Moola KS, Challa BSR, Chandrasekhar KB. Bioanalytical method development and validation of eszopiclone in rabbit plasma by HPLC-MS/MS and its application to pharmacokinetic study. Int J Biol Pharm Res. 2014;5(9):719-27.
Pilla N, Chandanam S, Sreenivas Rao T, Veera Reddy S. Development and validation of liquid chromatography-tandem mass pectrometry for determination of olanzapine in rabbit plasma. DHR Int J Pharm Sci. 2014;5(1):151-9.
Chandrasekar MJN, Chandrasekar AJ, Krishnaraj K, Muralidharan S, Rajan S, Suresh B. Liquid chromatography-mass spectrometry determination of Cetrizine hydrochloride in rabbit plasma. Asian J Chem. 2009;21(8):5821-8.
Kaza M, Karazniewicz Lada M, Kosicka K, Siemiatkowska A, Rudzki PJ. Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse? J Pharm Biomed Anal. 2019;165:381-5. doi: 10.1016/j.jpba.2018.12.030, PMID 30590335.
Smith G. European medicines agency guideline on bioanalytical method validation: what more is there to say? Bioanalysis. 2012;4(8):865-8. doi: 10.4155/bio.12.44, PMID 22533559.
Li X, Shi X, Qin X, Yu L, Zhou Y, Rao C. Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant human erythropoietin. Anal Methods. 2020;12(30):3836-43. doi: 10.1039/d0ay00823k, PMID 32678383.
Del Mar Ramírez Fernández M, Wille SM, Samyn N. Quantitative method validation for the analysis of 27 antidepressants and metabolites in plasma with ultraperformance liquid chromatography-tandem mass spectrometry. Ther Drug Monit. 2012;34(1):11-24. doi: 10.1097/FTD.0b013e31823bf0fd, PMID 22210095.
Wozniakiewicz M, Wietecha Posłuszny R, Moos A, Wieczorek M, Knihnicki P, Koscielniak P. Development of microextraction by packed sorbent for toxicological analysis of tricyclic antidepressant drugs in human oral fluid. J Chromatogr A. 2014;1337:9-16. doi: 10.1016/j.chroma.2014.02.037, PMID 24636563.
Chambers EE, Woodcock MJ, Wheaton JP, Pekol TM, Diehl DM. Systematic development of an UPLC-MS/MS method for the determination of tricyclic antidepressants in human urine. J Pharm Biomed Anal. 2014;88:660-5. doi: 10.1016/j.jpba.2013.09.001, PMID 24239905.
Patel DS, Sharma N, Patel MC, Patel BN, Shrivastav PS, Sanyal M. Development and validation of a selective and sensitive LC-MS/MS method for determination of cycloserine in human plasma: application to bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 2011;879(23):2265-73. doi: 10.1016/j.jchromb.2011.06.011, PMID 21727043.
Yadav M, Shrivastav PS. Incurred sample reanalysis (ISR): a decisive tool in bioanalytical research. Bioanalysis. 2011;3(9):1007-24. doi: 10.4155/bio.11.76, PMID 21545349.
Lolla S, Gubbiyappa KS, Cheruku S, Bhikshapathi DVRN. Validation of an LC-MS/MS method for quantitation of fostemsavir in plasma. J Pharmacol Toxicol Methods. 2023;120:107254. doi: 10.1016/j.vascn.2023.107254, PMID 36863666.
Sandhya P, Shankar CH, Bhikshapathi DVRN, Mamatha P. An LC–MS/MS quantification method development and validation for the dabrafenib in biological matrices. Sai Uday Kiran G J Appl Pharm Sci. 2023;13(1):180-6.
Published
How to Cite
Issue
Section
Copyright (c) 2024 PHANI KUMAR SUNKARA, SREEDHARA CHAGANTY, K. RAMAKRISHNA
This work is licensed under a Creative Commons Attribution 4.0 International License.
