UPLC MS/MS method for quantification of mycophenolic acid and metabolites in human plasma: Application to pharmacokinetic study

Clinica Chimica Acta

Volumn 412, Issue 1-2, 2011, Pages 59-65

  Delavenne, Xavier ^a   Juthier, Ludivine ^a   Pons, Bertrand ^a   Mariat, Christophe ^a   Basset, Thierry ^a  

^a UNIVERSITY HOSPITAL OF SAINT ETIENNE   (France)

Author keywords

Metabolite; Mycophenolic acid; Pharmacokinetics; UPLC MS MS

Indexed keywords

ACYL MYCOPHENOLIC ACID GLUCURONIDE; DRUG METABOLITE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID BETA D GLUCURONIDE; UNCLASSIFIED DRUG;

ACCURACY; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DOSE REDUCTION; ENTERIC COATED TABLET; HUMAN; MAXIMUM PLASMA CONCENTRATION; POSITIVE ION ELECTROSPRAY; PRECIPITATION; PRIORITY JOURNAL; PROCESS DEVELOPMENT; QUALITY CONTROL; QUANTITATIVE ANALYSIS; SENSIBILITY; SEPARATION TECHNIQUE; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDATION PROCESS;

BLOOD CHEMICAL ANALYSIS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; GLUCURONIDES; HUMANS; KIDNEY TRANSPLANTATION; MYCOPHENOLIC ACID; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; TANDEM MASS SPECTROMETRY; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78651463420     PISSN: 00098981     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cca.2010.09.041     Document Type: Article

References (35)

1. Franklin T.J., Cook J.M. The inhibition of nucleic acid synthesis by mycophenolic acid. Biochem J 1969, 113:515-524.
2. Picard N., Ratanasavanh D., Prémaud A., Le Meur Y., Marquet P. Identification of UDP-glucuronosyltransferase isoforms involved in mycophenolic acid phase II metabolism. Drug Metab and Dispos 2005, 33:139-146.
3. Johnson A.G., Rigby R.J., Taylor P.J. The kinetics of mycophenolic acid and its glucuronide metabolite in adult kidney transplant recipients. Clin Pharmacol Ther 1999, 66:492-500.
4. van Gelder T., Le Meur Y., Shaw L.M., et al. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit 2006, 28:145-154.
5. Oellerich M., Armstrong V.W. The role of therapeutic drug monitoring in individualizing immunosuppressive drug therapy: recent developments. Ther Drug Monit 2006, 28:720-725.
6. Le Guellec C., Bourgoin H., Büchler M., et al. Population pharmacokinetics and Bayesian estimation of mycophenolic acid concentrations in stable renal transplant patients. Clin Pharmacokinet 2004, 43:253-266.
7. Prémaud A., Le Meur Y., Debord J., et al. Maximum a posteriori bayesian estimation of mycophenolic acid pharmacokinetics in renal transplant recipients at different postgrafting periods. Ther Drug Monit 2005, 27:354-361.
8. Hulin A., Blanchet B., Audard V., et al. Comparison of 3 estimation methods of mycophenolic acid AUC based on a limited sampling strategy in renal transplant patients. Ther Drug Monit 2009, 31:224-232.
9. Mino Y., Naito T., Matsushita T., Kagawa Y., Kawakami J. Simultaneous determination of mycophenolic acid and its glucuronides in human plasma using isocratic ion pair high - performance liquid chromatography. J Pharm Biomed Anal 2008, 46:603-608.
10. Cussonneau X., Bolon-Larger M., Prunet-Spano C., Bastien O., Boulieu R. Relationship between MPA free fraction and free MPAG concentrations in heart transplant recipients based on simultaneous HPLC quantification of the target compounds in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2007, 852:674-678.
11. Yau W.P., Vathsala A., Lou H.X., Zhou S.F., Chan E. Simple Reversed-phase liquid chromatographic assay for simultaneous quantification of free mycophenolic acid and its glucuronide metabolite in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2007, 846:313-318.
12. Bolon M., Jeanpierre L., Ei Barkil M., Chelbi K., Sauviat M., Boulieu R. HPLC determination of mycophenolic acid and mycophenolic acid glucuronide in human plasma with hybrid material. J Pharm Biomed Anal 2004, 36:649-651.
13. Westley I.S., Sallustio B.C., Morris R.G. Validation of a high-performance liquid chromatography method for the measurement of mycophenolic acid and its glucuronide metabolites in plasma. Clin Biochem 2005, 38:824-829.
14. Indjova D., Kassabova L., Svinarov D. Simultaneous determination of mycophenolic acid and its phenolic glucuronide in human plasma using an isocratic high-performance liquid chromatography procedure. J Chromatogr B Analyt Technol Biomed Life Sci 2005, 817:327-330.
15. Aresta A., Palmisano F., Zambonin C.G., Schena P., Grandaliano G. Simultaneous determination of free mycophenolic acid and its glucuronide in serum of patients under mycophenolate mophetil therapy by ion-pair reversed-phase liquid chromatography with diode array UV detection. J Chromatogr B Analyt Technol Biomed Life Sci 2005, 810:197-202.
16. Yau W.P., Vathsala A., Lou H.X., Chan E. Sample reversed-phase ion-pair liquid chromatography assay for the simultaneous determination of mycophenolic acid and its glucuronide metabolite in human plasma and urine. J Chromatogr B Analyt Technol Biomed Life Sci 2004, 805:101-112.
17. Watson D.G., Araya F.G., Galloway P.J., Beattie T.J. Development of a high pressure liquid chromatography method for the determination of mycophenolic acid and its glucuronide metabolite in small volumes of plasma from paediatric patients. J Pharm Biomed Anal 2004, 35:87-92.
18. Khosschsorur G., Erwa W. Liquid chromatographic method for simultaneous determination of mycophenolic acid and its phenol-and acylglucuronide metabolites in plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2004, 799:355-360.
19. Atcheson B., Taylor P.J., Mudge D.W., Johnson D.W., Pillans P.I., Tett S.E. Quantification of free mycophenolic acid and its glucuronide metabolite in human plasma by liquid-chromatography using mass spectrometric and ultraviolet absorbance detection. J Chromatogr B Analyt Technol Biomed Life Sci 2004, 799:157-163.
20. Zivanovic L., Protic A., Zecevic M., Jocic B., Kostic M. Multicriteria optimization methodology in development of HPLC separation of mycophenolic acid and mycophenolic acid glucuronide in human urine and plasma. J Pharm Biomed Anal 2009, 50:640-648.
21. Elbarbry F.A., Shoker A.S. Liquid chromatographic determination of mycophenolic acid and its metabolites in human kidney transplant plasma: pharmacokinetic application. J Chromatogr B Analyt Technol Biomed Life Sci 2007, 859:276-281.
22. Hosotsubo H., Takahara S., Kokado Y. Rapid and simultaneous determination of mycophenolic acid and its glucuronide conjugate in human plasma by ion-pair reversed phase high-performance liquid chromatography using isocratic elution. J Chromatogr B Analyt Technol Biomed Life Sci 2001, 753:315-320.
23. Tsina I., Chu F., Hama K., et al. Manual and automated (robotic) high-performance liquid chromatography methods for the determination of mycophenolic acid and its glucuronide conjugate in human plasma. J Chromatogr B Biomed Appl 1996, 675:119-129.
24. Annesley T.M., Clayton L.T. Quantification of mycophenolic acid and glucuronide metabolite in human serum by HPLC-tandem mass spectrometry. Clin Chem 2005, 51:872-877.
25. DiFrancesco R., Frerichs V., Donnelly J., Hagler C., Hochreiter J., Tornatore K.M. Simultaneous determination of cortisol, dexamethasone, methylprednidolone, prednisolone, mycophenolic acid and mycophenolic acid glucuronide in human plasma utilizing liquid-chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed life sci 2007, 859:42-51.
26. Patel C.G., Mendonza A.E., Akhlaghi F., et al. Determination of total mycophenolic acid and its glucuronide metabolite using liquid chromatography with ultraviolet detection and unbound mycophenolic acid using tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2004, 813:287-294.
27. Benoit-Biancamano M.O., Caron P., Lévesque E., Delage R., Couture F., Guillemette C. Sensitive high-performance liquid chromatography-tandem mass spectrometry method for quantitative analysis of mycophenolic acid and its glucuronide metabolites in human plasma and urine. J Chromatogr B Analyt Technol Biomed Life Sci 2007, 858:159-167.
28. Figurski M.J., Korecka M., Fields L., Waligorska T., Shaw L.M. High-performance liquid chromatography-mass spectroscopy/mass spectroscopy method for simultaneous quantification of total or free fraction of mycophenolic acid and its glucuronide metabolites. Ther Drug Monitoring 2009, 31:717-726.
29. Brandhorst G., Streit F., Goetze S., Oellerich M., Armonstrong V.W. Quantification by liquid chromatography tandem mass spectrometry of mycophenolic acid and its phenol and acyl glucuronide metabolites. Clin Biochem 2006, 52:1962-1964.
30. Bahrami G., Mohammadi B. An isocratic high performance liquid chromatographic method for quantification of mycophenolic acid and its glucuronide metabolite in human serum using liquid-liquid extraction application to human pharmacokinetic studies. Clin Chim Acta 2006, 370:185-190.
31. Kuhn J., Prante C., Kleesiek K., Götting C. Measurement of mycophenolic acid and its glucuronide using a novel rapid liquid chromatography-electrospray ionization tandem mass spectrometry assay. Clim Biochem 2009, 42:42-51.
32. Musuamba F.T., DiFazio V., Vambinst R., Wallemacq P. A fast ultra-performance liquid chromatography method for simultaneous quantification of mycophenolic acid and its phenol- and acyl-glucuronides in human plasma. Ther Drug Monit 2009, 31:110-115.
33. Kuhn J., Götting C., Kleesiek K. Sample Cleanup-free determination of mycophenolic acid and its glucuronide in serum and plasma using the novel technology of ultra-performance liquid chromatography electrospray ionization tandem mass spectrometry. Talanta 2010, 80:1894-1898.
34. US Food and Drug Administration Guidance for industry. Bioanalytical method validation May 2001, http://www.fda.gov/cder/guidance/index.htm (accessed July 2010).
35. Stokvis E., Rosing H., López-Lázaro L., Schellens J.H.M., Beijnen J.H. Switching from an analogous to a stable isotopically labeled internal standard for the LC-MS/MS quantitation of the novel anticancer drug Kahalalide F significantly improves assay performance. Biomed Chromatogr 2004, 18:400-402.