[논문]Isotope–labeled versus analog internal standard in LC–MS/MS method for tacrolimus determination in human whole blood samples – A compensation of matrix effects

Bodnar-Broniarczyk, Magdalena; Pawiń; ski, Tomasz; Kunicki, Paweł K.

doi:10.1016/j.jchromb.2018.11.026

Isotope–labeled versus analog internal standard in LC–MS/MS method for tacrolimus determination in human whole blood samples – A compensation of matrix effects

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, v.1104, 2019년, pp.220 - 227

Bodnar-Broniarczyk, Magdalena (Department of Drug Chemistry, Faculty of Pharmacy, Medical University of Warsaw) , Pawiński, Tomasz (Department of Drug Chemistry, Faculty of Pharmacy, Medical University of Warsaw) , Kunicki, Paweł K. (Department of Drug Chemistry, Faculty of Pharmacy, Medical University of Warsaw)

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Abstract The aim of this work was to develop and to validate LC–MS/MS method for tacrolimus (TAC) determination in whole blood samples using two different types of internal standards (IS): an isotope-labeled TAC13C,D2 and a structural analog ascomycin (ASC). Matrix effects (ME) were evaluated to determine their influence on validation parameters. The LC–MS/MS analyses were performed using a 4000 QTRAP® mass spectrometer (AB Sciex) coupled to a HPLC 1260 Infinity system (Agilent Technologies). The [M + NH4]+ adducts were monitored with mass transitions of: 821.5 → 768.4 m/z for TAC, 809.5 → 756.4 m/z for ASC, and 824.6 → 771.5 m/z for TAC13C,D2. Blood samples were treated with 0.1 mol/L zinc sulfate - acetonitrile (50:50, v/v) then extracted with tert-butyl methyl ether. ME evaluations were performed by preextraction addition (n = 6), postextraction addition (n = 8), and repeated measures (n = 8) of reference solutions, separately for both ISs. ME, absolute recovery (AR) and process efficiency (PE) were calculated. Low (1.5 ng/mL) and high (16 ng/mL) TAC concentrations were tested. The method was successfully calibrated in a range of: 0.5–20 ng/mL. Both ISs provided satisfactory imprecision (<3.09% and <3.63% for TAC13C,D2 and ASC, respectively) and accuracy (99.55–100.63% and 97.35–101.71% for TAC13C,D2 and ASC, respectively). Similar ARs were found for all three compounds yielding: 74.89–76.36% for TAC, 78.37% for TAC13C,D2 and 75.66% for ASC. Significant ME were observed yielding on the average: −16.04% and −29.07% for TAC, −16.64% for TAC13C,D2 and −28.41% for ASC. Consequently, PE was 64.11% and 53.12% for TAC, 65.35% for TAC13C,D2 and 54.18% for ASC. ME for TAC were perfectly compensated (TAC/IS ratio) in each sample resulting in mean percent value of: 0.89% and −0.97% for TAC13C,D2 and ASC, respectively. An IS ascomycin presented a performance equivalent to TAC13C,D2 in LC–MS/MS method developed for TAC monitoring. Highlights Method parameters are satisfactory for application to pharmacokinetic studies and TDM. Ascomycin presents a performance equivalent to TAC13C,D2 in LC–MS/MS method for TAC. Matrix effects are successfully compensated by both internal standards.

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참고문헌 (48)

Drugs Scott 63 1247 2003 10.2165/00003495-200363120-00006 Tacrolimus: a further update of its use in the management of organ transplantation

상세보기
Ther. Drug Monit. Wallemacq 31 139 2009 10.1097/FTD.0b013e318198d092 Opportunities to optimize tacrolimus therapy in solid organ transplantation: report of the European consensus conference

상세보기
J. Chromatogr. B Taylor 883-884 108 2012 10.1016/j.jchromb.2011.06.024 Therapeutic drug monitoring of tacrolimus by liquid chromatography-tandem mass spectrometry: is it truly a routine test?

상세보기
Clin. Pharmacokinet. Staatz 43 623 2004 10.2165/00003088-200443100-00001 Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation

상세보기
Clin. Pharmacokinet. Staatz 54 993 2015 10.1007/s40262-015-0282-2 Clinical pharmacokinetics of once-daily tacrolimus in solid-organ transplant patients

상세보기
Trends Anal. Chem. Shipkova 84 23 2016 10.1016/j.trac.2016.01.031 Liquid chromatography tandem mass spectrometry for therapeutic drug monitoring of immunosuppressive drugs: achievements, lessons and open issues

상세보기
Ther. Drug Monit. Seger 38 170 2016 10.1097/FTD.0000000000000269

상세보기
Ther. Drug Monit. Christians 37 718 2015 10.1097/FTD.0000000000000205 Impact of laboratory practices on interlaboratory variability in therapeutic drug monitoring of immunosuppressive drugs

상세보기
Clin. Chem. Annesley 59 1630 2013 10.1373/clinchem.2013.209114 Standardization of LC-MS for therapeutic drug monitoring of tacrolimus

상세보기
Clin. Biochem. Vogeser 41 649 2008 10.1016/j.clinbiochem.2008.02.017 A decade of HPLC-MS/MS in the routine clinical laboratory-goals for further developments

상세보기
Drug Test Anal. Zhang 10 81 2018 10.1002/dta.2290 Recent advances in analytical methods for the therapeutic drug monitoring of immunosuppressive drugs

상세보기
Ther. Drug Monit. Dubbelboer 34 134 2012 10.1097/FTD.0b013e31824b0bfb Quantification of tacrolimus and three demethylated metabolites in human whole blood using LC-ESI-MS/MS

상세보기
Ann. Transplant. Korecka 14 61 2009 Review of the newest HPLC methods with mass spectrometry detection for determination of immunosuppressive drugs in clinical practice
Clin. Chim. Acta McShane 454 1 2016 10.1016/j.cca.2015.12.027 Therapeutic drug monitoring of immunosuppressants by liquid chromatography-mass spectrometry

상세보기
Clin. Biochem. Shipkova 49 1009 2016 10.1016/j.clinbiochem.2016.05.001 LC-MS/MS as a tool for TDM services: where are we?

상세보기
J. Chromatogr. B Adaway 883-884 33 2012 10.1016/j.jchromb.2011.09.041 Therapeutic drug monitoring and LC-MS/MS

상세보기
Clin. Biochem. Sallustio 44 231 2011 10.1016/j.clinbiochem.2010.10.005 Comparison of blood sirolimus, tacrolimus and everolimus concentrations measured by LC-MS/MS, HPLC-UV and immunoassay methods

상세보기
Clin. Biochem. Marinova 46 1723 2013 10.1016/j.clinbiochem.2013.08.013 Immunosuppressant therapeutic drug monitoring by LC-MS/MS: workflow optimization through automated processing of whole blood samples

상세보기
J. Chromatogr. B Koop 926 54 2013 10.1016/j.jchromb.2013.02.035 Analysis of tacrolimus and creatinine from a single dried blood spot using liquid chromatography tandem mass spectrometry

상세보기
Ther. Drug Monit. Taylor 22 608 2000 10.1097/00007691-200010000-00017 Simultaneous quantification of tacrolimus and sirolimus, in human blood, by high-performance liquid chromatography-tandem mass spectrometry

상세보기
Curr. Trends Biotechnol. Pharm. Patil 21 2010 Simple, rapid and sensitive method for determination of tacrolimus in human blood by using liquid chromatography/tandem mass spectrometry
BMC Clin. Pharmacol. Buchwald 12 2 2012 10.1186/1472-6904-12-2 Validation of an LC-MS/MS method to determine five immunosupresants with deuterated internal standards including MPA

상세보기
J. Chromatogr. B Ramakrishna 805 13 2004 10.1016/j.jchromb.2004.02.002 Liquid chromatography negative ion electrospray tandem mass spectrometry method for the quantification of tacrolimus in human plasma and its bioanalytical applications

상세보기
Clin. Chem. Streit 48 955 2002 10.1093/clinchem/48.6.955 Rapid liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of sirolimus, everolimus, tacrolimus, and cyclosporin a in whole blood

상세보기
Arch. Pathol. Lab. Med. Wang 129 661 2005 10.5858/2005-129-0661-AFASHL A fast and simple high-performance liquid chromatography/mass spectrometry for simultaneous measurement of whole blood tacrolimus and sirolimus

상세보기
Ther. Drug Monit. Koster 31 116 2009 10.1097/FTD.0b013e318192304c Robust, high-throughput LC-MS/MS metod for therapeutic drug monitoring of cyclosporine, tacrolimus, everolimus and sirolimus in whole blood

상세보기
J. Chromatogr. B Christians 748 41 2000 10.1016/S0378-4347(00)00380-7 Automated, fast and sensitive quantification of drugs in blood by liquid chromatography-mass spectrometry with on-line extraction: immunosuppressants

상세보기
Clin. Chem. Taylor 51 1890 2005 10.1373/clinchem.2005.055160 Evaluation of 3 internal standards for the measurement of cyclosporin by HPLC-mass spectrometry

상세보기
Clin. Chem. Lab. Med. Valbuena 54 437 2016 10.1515/cclm-2015-0519 Comparing the effect of isotopically labeled or structural analog internal standards on the performance of a LC-MS/MS method to determine ciclosporin A, everolimus, sirolimus and tacrolimus in whole blood

상세보기
Ther. Drug Monit. Gonschior 17 504 1995 10.1097/00007691-199510000-00011 Simplified high-performance liquid chromatography mass spectrometry assay for measurement of tacrolimus and its metabolites and cross-validation with microparticle enzyme immunoassay

상세보기
Arch. Pharm. Res. Park 39 73 2016 10.1007/s12272-015-0681-9 A rapid and sensitive method to determine tacrolimus in rat whole blood using liquid-liquid extraction with mild temperature ultrasonication and LC-MS/MS

상세보기
Ther. Drug Monit. Saitman 38 300 2016 10.1097/FTD.0000000000000252 Evaluation of the waters MassTrak LC-MS/MS assay for tacrolimus and a comparison to the Abbott Architect immunoassay

상세보기
Ther. Drug Monit. Korecka 33 460 2011 Evaluation of performance of new, isotopically labeled internal standard ([13c2d4]RAD001) for everolimus using a novel high-performance liquid chromatography tandem mass spectrometry method

상세보기
Ther. Drug Monit. Taylor 29 131 2007 10.1097/FTD.0b013e31802c0787 Internal standard selection for immunosuppressant drugs measured by high-performance liquid chromatography tandem mass spectrometry

상세보기
Clin. Chem. Vogeser 54 1406 2008 10.1373/clinchem.2008.105643 Instrument-specific matrix effects of calibration materials in the LC-MS/MS analysis of tacrolimus

상세보기
J. Chromatogr. B van Eeckhaut 877 2198 2009 10.1016/j.jchromb.2009.01.003 Validation of bioanalytical LC-MS/MS assays: evaluation of matrix effects

상세보기
Ther. Drug Monit. George 40 1 2018 10.1097/FTD.0000000000000471 Enhancement and suppression of ionization in drug analysis using HPLC-MS/MS in support of therapeutic drug monitoring: a review of current knowledge of its minimization and assessment

상세보기
Clin. Chem. Annesley 49 1041 2003 10.1373/49.7.1041 Ion suppression in mass spectrometry

상세보기
2011 Guideline on Bioanalytical Method Validation, EMEA/CHMP/EWP/192217/2009 Rev.1 Corr.2
Anal. Chem. Matuszewski 75 3019 2003 10.1021/ac020361s Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS

상세보기
Clin. Biochem. Taylor 38 328 2005 10.1016/j.clinbiochem.2004.11.007 Matrix effects: the Achilles heel of quantitative high performance liquid chromatography-electrospray-tandem mass spectrometry

상세보기
Rapid Commun. Mass Spectrom. Stokvis 19 401 2005 10.1002/rcm.1790 Stable isotopically labeled internal standards in quantitative bioanalysis using liquid chromatography/mass spectrometry: necessity or not?

상세보기
Clin. Chem. O'Halloran 54 1386 2008 10.1373/clinchem.2008.103952 Evaluation of a deuterium-labeled internal standard for the measurement of sirolimus by high-throughput HPLC electrospray ionization tandem mass spectrometry

상세보기
Ther. Drug Monit. Meinitzer 32 61 2010 10.1097/FTD.0b013e3181c49a00 Ultra-fast liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of cyclosporin A, tacrolimus, sirolimus, and everolimus in whole blood using deuterated internal standards for cyclosporin A and everolimus

상세보기
Sim 10 27 2014 52nd Annual Scientific Conference of Australasian Association of Clinical Biochemists, Adelaide The importance of stable isotope internal standards for the LC-MS/MS analysis of immunosuppressant drugs in whole blood
Scand. J. Clin. Lab. Invest. Vethe 70 583 2010 10.3109/00365513.2010.531141 Determination of cyclosporine, tacrolimus, sirolimus and everolimus by liquid chromatography coupled to electrospray ionization and tandem mass spectrometry: assessment of matrix effects and assay performance

상세보기
J. Chromatogr. A Tron 75 55 2016 10.1016/j.chroma.2016.10.075 A high performance liquid chromatography tandem mass spectrometry for the quantification of tacrolimus in human bile in liver transplant recipients

상세보기
Clin. Chem. Levine 57 1739 2011 10.1373/clinchem.2011.172080 The need for standardization of tacrolimus assays

상세보기

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Isotope–labeled versus analog internal standard in LC–MS/MS method for tacrolimus determination in human whole blood samples – A compensation of matrix effects

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