An UPLC-MS/MS method coupled with automated on-line SPE for quantification of tacrolimus in peripheral blood mononuclear cells

Journal of Pharmaceutical and Biomedical Analysis

Volumn 107, Issue , 2015, Pages 512-517

  Pensi, Debora ^a   De Nicolò, Amedeo ^a   Pinon, Michele ^b   Calvo, Pier Luigi ^b   Nonnato, Antonello ^c   Brunati, Andrea ^b   Di Perri, Giovanni ^a   D'Avolio, Antonio ^a  

^a UNIVERSITY OF TURIN   (Italy)

^b UNIVERSITY OF TURIN   (Italy)

^c CITTÀ DELLA SALUTE E DELLA SCIENZA HOSPITAL   (Italy)

Author keywords

FK 506; Intracellular; OSM; PBMC; Tandem mass

Indexed keywords

IMMUNOSUPPRESSIVE AGENT; TACROLIMUS;

ADOLESCENT; ANALYTIC METHOD; ANALYTICAL EQUIPMENT; ARTICLE; AUTOMATION; CHILD; CLINICAL ARTICLE; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN CELL; IMMUNOSUPPRESSIVE TREATMENT; LIMIT OF QUANTITATION; LIVER GRAFT REJECTION; LIVER TRANSPLANTATION; MASS SPECTROMETER; MASS SPECTROMETRY; MEASUREMENT ACCURACY; ONLINE ANALYSIS; PERIPHERAL BLOOD MONONUCLEAR CELL; PRACTICE GUIDELINE; PRESCHOOL CHILD; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SCHOOL CHILD; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION; SOLID PHASE EXTRACTION COLUMN; TARGET CELL; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDATION PROCESS; BLOOD; CALIBRATION; CHEMISTRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MONONUCLEAR CELL; PROCEDURES; STANDARD; TANDEM MASS SPECTROMETRY;

ADOLESCENT; CALIBRATION; CHILD; CHILD, PRESCHOOL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LEUKOCYTES, MONONUCLEAR; REFERENCE STANDARDS; SENSITIVITY AND SPECIFICITY; TACROLIMUS; TANDEM MASS SPECTROMETRY;

EID: 84923039383     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2015.01.054     Document Type: Article

References (31)

1. EMEA Scientific Discussion http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000712/WC500022237.pdf.
2. Capron A., Lerut J., Latinne D., Rahier J., Haufroid V., Wallemacq P. Correlation of tacrolimus levels in peripheral blood mononuclear cells with histological staging of rejection after liver transplantation: preliminary results of a prospective study. Transpl. Int. 2011, 25:41-47.
3. Taylor P.J., Franklin M.E., Tai C.H., Pillans P.I. Therapeutic drug monitoring of tacrolimus by liquid chromatography-tandem mass spectrometry: is it truly a routine test?. J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci. 2011, 883-884:108-112.
4. Zahir H., McCaughan G., Gleeson M., Nand R.A., McLachlan A.J. Changes in tacrolimus distribution in blood and plasma protein binding following liver transplantation. Ther. Drug Monit. 2004, 26:506-515.
5. Chow F.S., Piekoszewski W., Jusko W.J. Effect of hematocrit and albumin concentration on hepatic clearance of tacrolimus (FK506) during rabbit liver perfusion. Drug Metab. Dispos. 1997, 25:610-616.
6. du Souich P., Verges J., Erill S. Plasma protein binding and pharmacological response. Clin. Pharmacokinet. 1993, 24:435-440.
7. Takada K., Katayama N., Kiriyama A., Usuda H. Distribution characteristics of immunosuppressants FK506 and cyclosporin A in the blood compartment. Biopharm. Drug Dispos. 1993, 14:659-671.
8. Zahir H., McCaughan G., Gleeson M., Nand R.A., McLachlan A.J. Factors affecting variability in distribution of tacrolimus in liver transplant recipients. Br. J. Clin. Pharmacol. 2003, 57:298-309.
9. Thomson A.W., Bonham C.A., Zeevi A. Mode of action of tacrolimus (FK506): molecular and cellular mechanisms. Ther. Drug Monit. 1995, 17:584-591.
10. Trull A.K., Shields M.D. Therapeutic monitoring of tacrolimus. Ann. Clin. Biochem. 1998, 35(Pt 2):167-180.
11. Volosov A., Napoli K.L., Soldin S.J. Simultaneous simple and fast quantification of three major immunosuppressants by liquid chromatography-tandem mass-spectrometry. Clin. Biochem. 2001, 34:285-290.
12. Karapirli M., Kizilgun M., Yesilyurt O., Gul H., Kunak Z.I., Akgul E.O., Macit E., Cayci T., Gulcan Kurt Y., Aydin I., Yaren H., Seyrek M., Cakir E., Yaman H. Simultaneous determination of cyclosporine A, tacrolimus, sirolimus, and everolimus in whole-blood samples by LC-MS/MS. Sci. World J. 2012, 2012:571201.
13. Streit F., Armstrong V.W., Oellerich M. Rapid liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of sirolimus, everolimus, tacrolimus, and cyclosporin A in whole blood. Clin. Chem. 2002, 48:955-958.
14. Tszyrsznic W., Borowiec A., Pawlowska E., Jazwiec R., Zochowska D., Bartlomiejczyk I., Zegarska J., Paczek L., Dadlez M. Two rapid ultra performance liquid chromatography/tandem mass spectrometry (UPLC/MS/MS) methods with common sample pretreatment for therapeutic drug monitoring of immunosuppressants compared to immunoassay. J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci. 2013, 928:9-15.
15. Capron A., Musuamba F., Latinne D., Mourad M., Lerut J., Haufroid V., Wallemacq P.E. Validation of a liquid chromatography-mass spectrometric assay for tacrolimus in peripheral blood mononuclear cells. Ther. Drug Monit. 2009, 31:178-186.
16. Lemaitre F., Antignac M., Fernandez C. Monitoring of tacrolimus concentrations in peripheral blood mononuclear cells: application to cardiac transplant recipients. Clin. Biochem. 2013, 46:1538-1541.
17. Lemaitre F., Blanchet B., Latournerie M., Antignac M., Houssel-Debry P., Verdier M.C., Dermu M., Camus C., Le Priol J., Roussel M., Zheng Y., Fillatre P., Curis E., Bellissant E., Boudjema K., Fernandez C. Pharmacokinetics and pharmacodynamics of tacrolimus in liver transplant recipients: inside the white blood cells. Clin. Biochem. 2014.
18. Roullet-Renoleau F., Lemaitre F., Antignac M., Zahr N., Farinotti R., Fernandez C. Everolimus quantification in peripheral blood mononuclear cells using ultra high performance liquid chromatography tandem mass spectrometry. J. Pharm. Biomed. Anal. 2012, 66:278-281.
19. FDA Guidance for Industry: Bioanalytical Method Validation http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf.
20. Taylor P.J. Matrix effects: the Achilles heel of quantitative high-performance liquid chromatography-electrospray-tandem mass spectrometry. Clin. Biochem. 2005, 38:328-334.
21. Agnesod D., De Nicolo A., Simiele M., Mohamed Abdi A., Boglione L., Di Perri G., D'Avolio A. Development and validation of a useful UPLC-MS/MS method for quantification of total and phosphorylated-ribavirin in peripheral blood mononuclear cells of HCV+ patients. J. Pharm. Biomed. Anal. 2014, 90:119-126.
22. D'Avolio A., Carcieri C., Cusato J., Simiele M., Calcagno A., Allegra S., Sciandra M., Trentini L., Di Perri G., Bonora S. Intracellular accumulation of atazanavir/ritonavir according to plasma concentrations and OATP1B1, ABCB1 and PXR genetic polymorphisms. J. Antimicrob. Chemother. 2014, 69:3061-3066.
23. D'Avolio A., Simiele M., Calcagno A., Siccardi M., Larovere G., Agati S., Baietto L., Cusato J., Tettoni M., Sciandra M., Trentini L., Di Perri G., Bonora S. Intracellular accumulation of ritonavir combined with different protease inhibitors and correlations between concentrations in plasma and peripheral blood mononuclear cells. J. Antimicrob. Chemother. 2013, 68:907-910.
24. D'Avolio A., Simiele M., De Francia S., Ariaudo A., Baietto L., Cusato J., Fava C., Saglio G., Di Carlo F., Di Perri G. HPLC-MS method for the simultaneous quantification of the antileukemia drugs imatinib, dasatinib and nilotinib in human peripheral blood mononuclear cell (PBMC). J. Pharm. Biomed. Anal. 2012, 59:109-116.
25. D'Avolio A., Simiele M., Siccardi M., Baietto L., Sciandra M., Oddone V., Stefani F.R., Agati S., Cusato J., Bonora S., Di Perri G. A HPLC-MS method for the simultaneous quantification of fourteen antiretroviral agents in peripheral blood mononuclear cell of HIV infected patients optimized using medium corpuscular volume evaluation. J. Pharm. Biomed. Anal. 2011, 54:779-788.
26. De Francia S., D'Avolio A., Ariaudo A., Pirro E., Piccione F., Simiele M., Fava C., Calcagno A., Di Perri G., Saglio G. Plasma and intracellular imatinib concentrations in patients with chronic myeloid leukemia. Ther. Drug Monit. 2014, 36:410-412.
27. De Nicolò A., Agnesod D., Simiele M., Rigano D., Adriani A., Canaparo R., Astegiano M., Rizzetto M., Di Perri G., D'Avolio A. UPLC-MS/MS method for quantification of the azathioprine metabolites 6-mercaptoguanosine and 6-methylmercaptopurine riboside in peripheral blood mononuclear cells. J. Pharm. Biomed. Anal. 2014, 98:271-278.
28. Simiele M., D'Avolio A., Baietto L., Siccardi M., Sciandra M., Agati S., Cusato J., Bonora S., Di Perri G. Evaluation of the mean corpuscular volume of peripheral blood mononuclear cells of HIV patients by a coulter counter to determine intracellular drug concentrations. Antimicrob. Agents Chemother. 2011, 55:2976-2978.
29. Jalil M.H., Hawwa A.F., McKiernan P.J., Shields M.D., McElnay J.C. Population pharmacokinetic and pharmacogenetic analysis of tacrolimus in paediatric liver transplant patients. Br. J. Clin. Pharmacol. 2013, 77:130-140.
30. D'Avolio A., Pensi D., Baietto L., Di Perri G. Therapeutic drug monitoring of intracellular anti-infective agents. J. Pharm. Biomed. Anal. 2014, 101:183-193.
31. Capron A., Lerut J., Verbaandert C., Mathys J., Ciccarelli O., Vanbinst R., Roggen F., De Reyck C., Lemaire J., Wallemacq P.E. Validation of a liquid chromatography-mass spectrometric assay for tacrolimus in liver biopsies after hepatic transplantation: correlation with histopathologic staging of rejection. Ther. Drug Monit. 2007, 29:340-348.