摘要
BioanalysisAhead of Print EditorialAssessment of matrix effect in quantitative LC-MS bioanalysisYunlin Fu, Wenkui Li & Franck PicardYunlin Fu *Author for correspondence: Tel.: +1 862 778 1726; E-mail Address: yunlin.fu@novartis.comhttps://orcid.org/0000-0003-2988-4447Pharmacokinetic Sciences, Novartis Biomedical Research, East Hanover, NJ 07936, USA, Wenkui Li https://orcid.org/0000-0002-1021-2766Pharmacokinetic Sciences, Novartis Biomedical Research, East Hanover, NJ 07936, USA & Franck PicardPharmacokinetic Sciences, Novartis Biomedical Research, CH-4056, Basel, SwitzerlandPublished Online:5 Apr 2024https://doi.org/10.4155/bio-2024-0047AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: LC-MS bioanalysismatrix effect • matrix factor • post-column infusion • post-extraction spiking • pre-extraction spikingReferences1. Matuszewski BK, Constanzer ML, Chavez-Eng CM. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS. Anal. Chem. 75(13), 3019–3030 (2003).Medline CASGoogle Scholar2. Bienvenu JF, Provencher G, Bélanger P et al. Standardized procedure for the simultaneous determination of the matrix effect, recovery, process efficiency, and internal standard association. Anal. Chem. 89(14), 7560–7568 (2017).Medline CASGoogle Scholar3. Huang Y, Shi R, Gee W, Bonderud R. Matrix effect and recovery terminology issues in regulated drug bioanalysis. Bioanalysis 4(3), 271–279 (2012).CASGoogle Scholar4. Li F, Ewles M, Pelzer M et al. Case studies: the impact of nonanalyte components on LC-MS/MS-based bioanalysis: strategies for identifying and overcoming matrix effects. Bioanalysis 5(19), 2409–2441 (2013).CASGoogle Scholar5. Nicolò AD, Cantù M, D'avolio A. Matrix effect management in liquid chromatography mass spectrometry: the internal standard normalized matrix effect. Bioanalysis 9(14), 1093–1105 (2017).Google Scholar6. Furey A, Moriarty M, Bane V, Kinsella B, Lehane M. Ion suppression; a critical review on causes, evaluation, prevention and applications. Talanta 115, 104–122 (2013).Medline CASGoogle Scholar7. Trivedi V, Upadhyay V, Yadav M, Shrivastav PS, Sanyal M. Impact of electrospray ion source platforms on matrix effect due to plasma phospholipids in the determination of rivastigmine by LC-MS/MS. Bioanalysis 6(17), 2301–2316 (2014).CASGoogle Scholar8. Cortese M, Gigliobianco MR, Magnoni F, Censi R, Di Martino P. Compensate for or minimize matrix effects? strategies for overcoming matrix effects in liquid chromatography-mass spectrometry technique: a tutorial review. Molecules 25(13), 3047 (2020).Medline CASGoogle Scholar9. EMA. ICH guideline M10 on bioanalytical method validation and study sample analysis (2022). https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdfGoogle Scholar10. Côté C, Bergeron A, Mess J-N, Furtado M, Garofolo F. Matrix effect elimination during LC-MS/MS bioanalytical method development. Bioanalysis 1(7), 1243–1257 (2009).CASGoogle Scholar11. Guo X, Lankmayr E. Phospholipid-based matrix effects in LC-MS bioanalysis. Bioanalysis 3(4), 349–352 (2011).CASGoogle Scholar12. Weaver R, Riley RJ. Identification and reduction of ion suppression effects on pharmacokinetic parameters by polyethylene glycol 400. Rapid Commun. Mass Spectrom. 20(17), 2559–2564 (2006).Medline CASGoogle Scholar13. Fu Y, Li W, Picard F. Non-regulated LC-MS/MS bioanalysis in support of early drug development: a Novartis perspective. Bioanalysis 15(3), 109–125 (2023).CASGoogle Scholar14. Dams R, Huestis MA, Lambert WE, Murphy CM. Matrix effect in bio-analysis of illicit drugs with LC-MS/MS: influence of ionization type, sample preparation, and biofluid. J. Am. Soc. Mass Spectrom. 14(11), 1290–1294 (2003).Medline CASGoogle Scholar15. Beccaria M, Cabooter D. Current developments in LC-MS for pharmaceutical analysis. Analyst 145(4), 1129–1157 (2020).Medline CASGoogle Scholar16. Fu Y, Barkley D, Li W, Picard F, Flarakos J. Evaluation, identification and impact assessment of abnormal internal standard response variability in regulated LC-MS bioanalysis. Bioanalysis 12(8), 545–559 (2020).CASGoogle ScholarFiguresReferencesRelatedDetails Ahead of Print STAY CONNECTED Metrics Downloaded 0 times History Received 22 February 2024 Accepted 26 March 2024 Published online 5 April 2024 Information© 2024 Expert Publishing Science Ltd trading as Taylor & FrancisKeywordsLC-MS bioanalysismatrix effect • matrix factor • post-column infusion • post-extraction spiking • pre-extraction spikingFinancial disclosureThe authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.Competing interests disclosureThe authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.Writing disclosureNo writing assistance was utilized in the production of this manuscript.PDF download