Comparison on two methods of HPLC-MS/MS and MEIA in monitoring the tacrolimus concentrations for organ transplantation patients

Abstract

Abstract: AIM: To compare two methods of HPLC-MS/MS and MEIA to monitor the tacrolimus concentrations for organ transplantation patient. METHODS: After developing and validating the HPLC-MS/MS method to determine the concentrations of tacrolimus, the tacrolimus samples were quantitated by two methods of HPLC-MS/MS and MEIA, respectively.Evaluate two methods by statistical analysis of quantitative results.RESULTS: The mean concentration were(4.86±0.46)ng/mL by HPLC-MS/MS and (5.52±0.43)ng/mL by MEIA.The coefficient correlation of two methods was 0.8771, and the two methods have good correlations in statistics.The mean concentration ratio was (90.3±5.3)%.CONCLUSION: The HPLC-MS/MS method is a more precise method for to determining the effective concentration of tacrolimus, which is suitable for daily TDM.

Key words: HPLC-MS/MS, microparticle enzyme immunoassay, organ transplantation, tacrolimus

CLC Number:

R969

LI Peng-fei, LIU Li-hong, MA Ping, DING Chun-lei, TONG Wei-hang. Comparison on two methods of HPLC-MS/MS and MEIA in monitoring the tacrolimus concentrations for organ transplantation patients[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(1): 80-83.

References

[1] 徐新军, 张正行, 刘皋林.新型免疫抑制剂他克莫司药物动学研究进展[J]. 国外医药-合成药, 生化药, 制剂分册, 2001, 22(2):93-96.
[2] 郑萍, 胡敏燕, 罗勤, 等.他克莫司对9 例肾移植病人的药物动力学[J]. 2001, 20(6):450-452.
[3] Salm P, Tay lor PJ, Clark A, et al. High-performance liquid chromatography-tandem mass spectrometry as a reference for analysis of tacrolimus to assess two immunoassays in patients with liver and renal transplants[J]. Ther Drug Monit, 1997, 19(6):694-700.
[4] Staatz CE, Taylor PJ, Tett SE.Comparison of an ELISA and an LC MS/MS method for measuring tacrolimus concentrations and making dosage decisions in transplant recipients[J]. Ther Drug Monit, 2002, 24(5):607-615.
[5] Amit KG, Steven JS.IMx tacrolimus II assay:is it reliable at low blood concentrations ? A comparison with tandem MS/MS[J]. Clin Biochem, 2002, 35(5):389-392.
[6] Andrew V, Kimberly LN, Steven JS.Simultaneous simple and fast quantification of three major immunosuppressants by liquid chromatography-tandem mass-spectrometry[J]. Clin Biochem, 2001, 34(4):285-290.
[7] Koal T, DietersM, Casetta B, et al. Simultaneous determination of four immunosuppressants by means of high speed and robust on-line solid phase extraction-high performance liquid chromatography-tandem mass spectrometry[J]. J Chromatogr B Analyt Technol Biomed Life Sci, 2004, 805(2):215-222.
[8] Frank S, Maria S, Victor WA, et al. Validation of a rapid and sensitive liquid chromatography-tandem mass spectrometry method for free and total mycophenolic acid[J]. Clin Chem, 2004, 50(1):152-159.
[9] Streit F, Armstromg VW, Oellerich M.Rapid liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of sirolimus, everolimus, tacrolimus, and cyclosporin A in whole blood[J]. Clin Chem, 2002, 48(6 Pt 1):955-958.
[10] Nigel W, Christopher EG, Jemimah EA, et al. Low hematocrit and serum albumin concentrations underlie the overestimation of tacrolimus concentrations by microparticle enzyme immunoassay versus liquid chromatography-tandem mass spectrometry[J]. Clin Chem, 2005, 51(3):586-592.

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[14]	XIN Huawen, YANG Yan. Association of synergistic effects of Wuzhi capsules on tacrolimus and PXR polymorphisms [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(10): 1138-1144.
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