A systematic approach for developing a robust LC-MS/MS method for bioanalysis

Bioanalysis

Volumn 5, Issue 1, 2013, Pages 91-115

  Meng, Min ^a   Wang, Laixin ^a   Voelker, Troy ^a   Reuschel, Scott ^a   Van Horne, K C ^b   Bennett, Patrick ^c  

^a Northwest Toxicology Inc   (United States)

^b SPEware Corp   (United States)

^c Thermo Fisher Scientific   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BIOASSAY; COMPUTER PROGRAM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; INTERMETHOD COMPARISON; LIQUID CHROMATOGRAPHY; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; QUANTITATIVE ANALYSIS; REVIEW; SEPARATION TECHNIQUE; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

CHEMISTRY TECHNIQUES, ANALYTICAL; CHROMATOGRAPHY, LIQUID; HUMANS; QUALITY CONTROL; TANDEM MASS SPECTROMETRY;

EID: 84871541043     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.295     Document Type: Review

References (37)

1. Shah VP, Midha KK, Dighe S et al. Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies. J. Pharm. Sci. 81(3), 309-312 (1992).
2. US FDA, Department of Health and Human Services. Guidance for the Industry. Bioanalytical Method Validation. FDA, Department of Health and Human Services, Rockville, MD, USA (2001).
3. Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. Pharm. Res. 24(10), 1962-1973 (2007).
4. Rocci ML, Devanarayan V, Haughey DB et al. Confirmatory reanalysis of incurred bioanalytical samples. AAPS J. 9(3), E336-E343 (2007).
5. Zhou S, Song Q, Tang Y, Naidong W. Critical review of development, validation, and transfer for high throughput bioanalytical LCYMS/MS methods. Curr. Pharma. Anal. 1(1), 3-14 (2005).
6. Liu GW, Snapp HM, Ji QC and Arnold ME. Strategy of accelerated method development for high-throughput bioanalytical assays using ultra high-performance liquid chromatography coupled with mass spectrometry. Anal. Chem. 81(22), 9225Y 9232 (2009).
7. Jemal M, Zheng O, Xia YQ. Systematic LCY MS/MS bioanalytical method development that incorporated plasma phospholipids risk avoidance, usage of incurred sample and well thought-out chromatography. Biomed. Chromatogr. 24(1), 2-19 (2010).
8. Kostiainen R, Kotiaho T, Kuuranne T, Auriola S. Liquid chromatography/atmospheric pressure ionization-MS in drug metabolism studies. J. Mass Spectrom. 38(4), 357-372 (2003).
9. Rodila R, Kim GE, Fan L et al. HPLCYMS/ MS determination of a hardly soluble drug in human urine through drug-albumin binding assisted dissolution. J. Chromatogr. B 872(1-2), 128-132 (2008).
10. Adler RS, Carter SJ, Voelker T. Overcoming challenges in development of LCYMS/MS methods for highly polar, low molecular weight, zwitterionic compounds: A quantitative assay for pregabalin. Presented at: The 2008 ASMS Conference. Denver, CO, USA, 1-5 June 2008.
11. Yamamoto EM, Rokushika S. Retention properties of the fluorinated bonded phase on LC of aromatic hydrocarbons. J. Chromatogr. A 898(2), 141-151 (2000).
12. Bennett PK, Meng M, Rohde L. Computer software-assisted chiral chromatographic method development for the quantitation of four chiral generic drugs in human plasma using LC/MS/MS. Presented at: The 2009 ASMS Conference. Philadelphia, PA, USA, 31 MayY4 June 2009.
13. Carter SJ, Čápka V, Vice S. An orthogonal approach to increasing assay ruggedness at low limits of quantition in LCYMS/MS assays. Presented at: The 2007 ASMS Conference. Indianapolis, IN, USA, 3-7 June 2007.
14. Voelker T, Tan L, Acheampong A et al. Two dimensional PPE/SPE extraction coupled with three dimensional HPLC/UPLCY MS/MS for a 500 fg/mL LLOQ assay. Presented at: The 2011 ASMS Conference. Denver, CO, USA, 5-9 June 2011.
15. Matuszewski BK, Constnzer ML, Chavez- Eng CM. Matrix effect in quantitative LCY MS/MS analyses of biological fluids: A method for determination of finasteride in human plasma at pictogram per milliliter concentrations. Anal. Chem. 70(5), 882-889 (1998).
16. Pascoe R, Foley JP, Gusev AI. Reduction in matrix related signal suppression effects in electropray ionization MS using on-line two dimensional liquid chromatography. Anal. Chem. 73(24), 6014-6023 (2001).
17. Ito S, Tsukada K. Matrix effect and correction by standard addition in quantitative liquid chromatographicYmass spectrometric analysis of diarrhetic shellfish poisoning toxins. J. Chromatogr. A 943(1), 39-46 (2001).
18. Hsieh Y, Chintala M, Mei H et al. Quantitative screening and matrix effect studies of drug discovery compounds in monkey plasma using fast-gradient liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 15(24), 2481-2487 (2001).
19. Zheng JJ, Lynch ED, Unger SE. Comparison of SPE and fast LC to eliminate mass spectrometric matrix effects from microsomal incubation products. J. Pharm. Biomed. Anal. 28(2), 279-285 (2002).
20. Mei H, Hsieh Y, Nardo, C et al. Investigation of matrix effects in bioanalytical high performance liquid chromatography/tandem mass spectrometric assays: Application to drug discovery. Rapid Commun. Mass Spectrom. 17(1), 97-103 (2003).
21. King R, Bonfiglio R, Fernandez-Metzler C et al. Mechanistic investigation of ionization suppression in electrospray ionization. J. Am. Soc. Mass Spectrom. 11(11), 942-950 (2000).
22. Ahnoff M, Wurzer A, Lindmark B, Jussila R. Characterization of serum albumin and lysoPCs as major contributors to plasma sample matrix effects on electrospray ionization efficiency. Presented at: 51st ASMS Conference on Mass Spectrometry. Montreal, QC, Canada, 8-12 June 2003.
23. Bennett PK, Van Horne KC. Identification of the major endogenous and persistent compounds in plasma, serum, and tissue that cause matrix effects with electrospray LC/MS techniques. Presented at: The 2003 AAPS Annual Meeting and Exposition. Salt Lake City, UT, USA, 26-30 October 2003.
24. Meng M, Bennett PK. Source for imprecision resulting from ionization suppression from strongly retained phospholipids and dioctyl phthalate. Presented at: The 52nd ASMS Conference on Mass Spectrometry. Nashville, TN, USA, 23-27 May 2004.
25. Little JL, Wempe MF, Buchanan CM. Liquid chromatographyYmass spectrometry/ mass spectrometry method development for drug metabolism studies: Examining lipid matrix ionization effects in plasma. J. Chromatogr. B 833(2), 219-230 (2006).
26. Du L, White RL. Reducing glycerophosphocholine lipid matrix interference effects in biological fluid assays by using high-turbulence liquid chromatography. Rapid Commun. Mass Spectrom. 22(21), 3362-3370 (2008).
27. Ismaiel OA, Halquist MS, Elmanly MY et al. Monitoring phospholipids for assessment of ion enhancement and ion suppression in ESI and APCI LC/MS/MS for chorpheniramine in human plasma and the importance of multiple source matrix effect evaluation. J. Chromatogr. B 875(2), 333-343 (2008).
28. Xia YQ, Jemal M. Phospholipids in liquid chromatography/MS bioanalysis: Comparison of three tandem mass spectrometric techniques for monitoring plasma phospholipids, the effect of mobile phase composition on phospholipids elution and the association of phospholipids with matrix effects. Rapid Commun. Mass Spectrom. 23(14), 2125-2138 (2009).
29. Peterson BL, Cummings BS. A review of chromatographic methods for the assessment of phospholipids in biological samples. Biomed. Chormatogr. 20(3) 227-243 (2006).
30. MacNeill R, Farside A, Acharya V et al. Implication of free cholesterol in LCYMS response enhancement. Bioanalysis 4(10), 1163-1173 (2012).
31. Bennett PK, Liang HR. Overcoming matrix effects resulting from biological phospholipids through selective extractions in quantitative LC/MS/MS. Presented at: The 52nd ASMS Conference on Mass Spectrometry. Nashville, TN, USA, 23-27 May 2004.
32. Van Horne KC, Bennett BK. Preventing matrix effects by using new sorbents to remove phospholipids from biological samples. Presented at: The 2003 AAPS Annual Meeting and Exposition. Salt Lake City, UT, USA, 26-30 October 2003.
33. Lanina SA, Toledo P, Sampels S et al. Comparison of reversed-phase liquid chromatographyYMS with electrospray and atmospheric pressure chemical ionization for analysis of dietary tocopherols. J. Chromatogr. A 1157(1-2), 159-170 (2007).
34. Curtis MA, Mastassa LC, Dermers R et al. Expanding the linear dynamic range in quantitative high performance liquid chromatography/tandem MS by the use of multiple product ions. Rapid Commun. Mass Spectrom. 15(12), 963-968 (2001).
35. Dolan JW. Attacking carryover problems. LC GC 19(10), 1050-1054 (2001).
36. Tan A, Hussain S, Musukub A, Massé R. Internal standard response variations during incurred sample analysis by LCYMS/MS: Case by case trouble shooting. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877(2), 3201-3209 (2009).
37. Meng M, Rohde L, Vladimír Čápka V et al. Fast chiral chromatographic method development and validation for the quantitation of eszopiclone in human plasma using LCYMS/MS. J. Pharm. Biomed. Anal. 53(4), 973-982 (2010).