Determination of carryover and contamination for mass spectrometry-based chromatographic assays
The Third American Association of Pharmaceutical Scientists/Food and Drug Administration Bioanalytical Workshop, held in 2006, reviewed and evaluated current practices and proposed that carryover and contamination be assessed not only during the validation of an assay but also during the application of the method in a study. In this article, the potential risks of carryover and contamination in each stage of a bioanalytical method are discussed, to explain to the industry why this recommendation is being made.
- Viswanathan, CT, Bansal, S, Booth, B (2007) Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J [serial online] 9: pp. E30-E42 CrossRef
- Zeng, W, Musson, DG, Fisher, AL (2006) Determination of MK-0431 in human plasma using high turbulence liquid chromatography online extraction and tandem mass spectrometry. Rapid Commun Mass Spectrom 20: pp. 1169-1175 CrossRef
- Dethy, JM, Ackermann, BL, Delatour, C (2003) Demonstration of direct bioanalysis of drugs in plasma using nanoelectrospray infusion from a silicon chip coupled with tandem mass spectrometry. Anal. Chem 75: pp. 805-811 CrossRef
- Chang, MS, Kim, EJ, El-Shourbagy, TA (2006) A novel approach for inprocess monitoring and managing cross-contamination in a high-throughput high-performance liquid chromatography assay with tandem mass spectrometric detection. Rapid Commun Mass Spectrom 20: pp. 2190-2200 CrossRef
- Chang MS, Kim EJ, El-Shourbagy TA. Managing bioanalytical cross-contamination. Available at: http://www.americanpharmaceuticalreview.com/articleDetail.asp? SID-02F0ABB61C2C47B6BAC99C9C6A00A8 4D&ArticleID-483. Accessed October 16, 2007.
- Mannonen S, Syrja, K. Liquid handling application notes. Available at: http://www.biohit.com/pdf/app11.pdf. Accessed October 16, 2007.
- Chang, MS, Kim, EJ, El-Shourbagy, TA (2007) Evaluation of 384-well formatted sample preparation technologies for regulated bioanalysis. Rapid Commun Mass Spectrom 21: pp. 64-72 CrossRef
- Lambert W. Analytical Pitfalls and Trends in Clinical and Forensic Toxicology. Joint GTFCh/TIAFT Symposium of the Analytical Conference; May 12, 2004; Munich, Germany. 2004; Available at: http://www.gtfch.org/tk/tk71_2/Lambert.pdf.Accessed November 1, 2007.
- Hedgepeth W, Steinike S. High Sensitivity MS Determination of Carryover in a New Autosampler Design. Application Note. Available at: http://www.ssi.shimadzu.com/products/pdfs/hplc/shimadzu-ABI_Carryove_PC2006.pdf. Accessed November 1, 2007.
- Elmashni D. HPLC Carryover—Decreased Sample Carryover Using the Finnigan Surveyor Autosampler. Application Note 330. Thermo Electron Corporation.
- Dolan JW. Autosampler Carryover. 2006; Available at: http://www.lcgceurope.com/lcgceurope/LC+Troubleshooting/Autosampler-Carryover/ ArticleStandard/Article/detail/377221. Accessed October 31, 2007.
- Tobien T, Bethem R. Problems and, Solutions for Carry-Over on High-Throughput LC Autosamplers. Proceedings of the 50th ASMS Conference on Mass Spectrometry and Allied Topics; June 2–6, 2002; Orlando, Florida. Available at: http://www.asms.org/asms02pdf/1891.pdf. Accessed November 1, 2007.
- Watanabe J, Hike H, Koura Y, Cueni H, Bando Y. Method Development of Minimizing Carry Over in LC/MS/MS-Novel Cleaning Technique and Device. Paper presented at: Proceedings of the 54th ASMS Conference on, Mass Spectrometry and Allied Topics; May 28–June 1, 2006; Seattle, Washington. 2006; Poster TP0118.
- Dolan JW. Autosampler Carryover. 2001; Available at: http://www.lcgceurope.com/lcgceurope/data/articlestandard// lcgceurope/042002/7657/article.pdf. Accessed October 31, 2007.
- Yamagishi Y. Utility of H-SRM to Reduce Matrix Interference in Food Residue Analysis of Pesticides by LC/MS/MS Using the Finnigan TSQ Quantum Discovery. Application Note 355. Thermo Scientific. 2005; Available at: http://www.thermo.com/eThermo/CMA/PDFs/Articles/articlesFile_28817.pdf. Accessed November 1, 2007.
- A Simple and Rapid LC-MS/MS Method for the Simultaneous Determination of Nine Antiretroviral Drugs Commonly Used in Europe (Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors). Application Note. Applied Biosystems. 2005; Available at: http://www3.appliedbiosystems.com/cms/groups/psm_marketing/ documents/generaldocuments/cms_042226.pdf. Accessed November 1, 2007.
- Organ A. Mux for Parallel LC-MS. CPSA Digest. New Technologies and Approaches for Increasing Drug Candidate Survivability: Lead Identification to Lead Optimization. October, 2001. Available at: http://www.milestonedevelopment.com/CPSA/2001/dayloc.3.html. Accessed October 31, 2007.
- Yang, L, Mann, TD, Little, D (2001) Evaluation of a four-channel multiplexed electrospray triple quadrupole mass spectrometer for the simultaneous validation of LC/MS/MS methods in four different preclinical matrixes. Anal Chem 73: pp. 1740-1747 CrossRef
- Thurmond M, Hodgin JC. Chromatographic factors affecting sample carry-over in the LC/MS analyses of small, molecules pharmaceuticals. Available at: http://www.nocarryover.com/Chromatographic-Tabloid.pdf. Accessed October 15, 2007.
- Rutters, H, Mohring, T, Rullkotter, J (2000) The persistent memory effect of triethylamine in the analysis of phospholipids by liquid chromatography/mass spectrometry. Rapid Commun Mass Spectrom 14: pp. 122-123 CrossRef
- Wickremsinhe, ER, Ackermann, BL, Chadhary, AK (2005) Validating regulatory-compliant wide dynamic range bioanalytical assays using chip-based nanoelectrospray tandem mass spectrometry. Rapid Commun Mass Spectrom 19: pp. 47-56 CrossRef
- Determination of carryover and contamination for mass spectrometry-based chromatographic assays
The AAPS Journal
Volume 9, Issue 3 , pp E353-E360
- Cover Date
- Online ISSN
- Additional Links
- memory effect
- Industry Sectors