A UFLC-MS/MS method coupled with one-step protein precipitation for determination of docetaxel in rat plasma: Comparative pharmacokinetic study of modified nanostructured lipid carrier

Journal of Pharmaceutical and Biomedical Analysis

Volumn 83, Issue , 2013, Pages 202-208

  Zhao, Xu ^a   Bi, Kaishun ^a   Wang, Xiaofan ^a   Xue, Xiao ^a   He, Bosai ^a   Cui, Yan ^a   Liu, Zhenzhen ^a   Wang, Dongkai ^a   Chen, Xiaohui ^a  

^a SHENYANG PHARMACEUTICAL UNIVERSITY   (China)

Author keywords

Docetaxel; One step protein precipitation; Pharmacokinetics; Polyethylene glycol; UFLC MS MS

Indexed keywords

DOCETAXEL; LIPID; MACROGOL; METHANOL; NANOCARRIER; NANOMATERIAL; WATER;

ANIMAL EXPERIMENT; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DETERMINATION; MALE; MOLECULAR WEIGHT; NONHUMAN; PRECIPITATION; PRIORITY JOURNAL; RAT; RELIABILITY; REPRODUCIBILITY; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

ANIMALS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CARRIERS; LIPIDS; MALE; NANOSTRUCTURES; POLYETHYLENE GLYCOLS; RATS; RATS, SPRAGUE-DAWLEY; TANDEM MASS SPECTROMETRY; TAXOIDS;

EID: 84879385803     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.05.025     Document Type: Article

References (31)

1. Lavelle F., Bissery M.C., Combeau C., Riou J.F., Vrignaud P., Andre S. Preclinical evaluation of docetaxel (Taxotere). Semin. Oncol. 1995, 22:3-16.
2. Clarke S.J., Rivory L.P. Clinical pharmacokinetics of docetaxel. Clin. Pharmacokinet. 1999, 36:99-114.
3. Savarese D.M., Halabi S., Hars V., Akerley W.L., Taplin M.E., Godley P.A., Hussain A., Small E.J., Vogelzang N.J. Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. Cancer and Leukemia Group B. J. Clin. Oncol. 2001, 19:2509-2516.
4. Simon G.R., Bunn P.A. Taxanes in the treatment of advanced (stage III and IV) non-small cell lung cancer (NSCLC): recent developments. Cancer Invest. 2003, 21:87-104.
5. Gilbert D.C., Parker C. Docetaxel for the treatment of prostate cancer. Future Oncol. 2005, 1:307-314.
6. Saloustros E., Georgoulias V. Docetaxel in the treatment of advanced non-small-cell lung cancer. Expert Rev. Anticancer Ther. 2008, 8:1207-1222.
7. Immordino M.L., Brusa P., Arpicco S., Stella B., Dosio F., Cattel L. Preparation, characterization, cytotoxicity and pharmacokinetics of liposomes containing docetaxel. J. Control. Release 2003, 91:417-429.
8. Baker S.D., Zhao M., He P., Carducci M.A., Verweij J., Sparreboom A. Simultaneous analysis of docetaxel and the formulation vehicle polysorbate 80 in human plasma by liquid chromatography/tandem mass spectrometry. Anal. Biochem. 2004, 324:276-284.
9. Klibanov A.L., Maruyama K., Torchilin V.P., Huang L. Amphipathic polyethyleneglycols effectively prolong the circulation time of liposomes. FEBS Lett. 1990, 268:235-252.
10. Zhao X., Zhao Y.L., Geng L.L., Li X., Wang X.F., Liu Z.Z., Wang D.K., Bi K.S., Chen X.H. Pharmacokinetics and tissue distribution of docetaxel by liquid chromatography-mass spectrometry: evaluation of folate receptor-targeting amphiphilic copolymer modified nanostructured lipid carrier. J. Chromatogr. B 2011, 879:3721-3727.
11. Peracchia M.T., Fattal E., Desmaele D., Besnard M., Noel J.P., Gomis J.M., Appel M., d'Angelo J., Couvreur P. Stealth PEGylated polycyanoacrylate nanoparticles for intravenous administration and splenic targeting. J. Control. Release 1999, 60:121-128.
12. Fundaro A., Cavalli R., Bargoni A., Vighetto D., Zara G.P., Gasco M.R. Non-stealth and stealth solid lipid nanoparticles (SLN) carrying doxorubicin: pharmacokinetics and tissue distribution after i.v. administration to rats. Pharm. Res. 2000, 42:337-343.
13. Mitra S., Gaur U., Ghosh P.C., Maitra A.N. Tumour targeted delivery of encapsulated dextran-doxorubicin conjugate using chitosan nanoparticles as carrier. J. Control. Release 2001, 74:317-323.
14. Rossi J., Giasson S., Khalid M.N., Delmas P., Allen C., Leroux J.C. Long-circulating poly(ethylene glycol)-coated emulsions to target solid tumors. Eur. J. Pharm. Biopharm. 2007, 67:329-338.
15. Liu B.R., Yang M., Li R.T., Ding Y.T., Qian X.P., Yu L.X., Jiang X.Q. The antitumor effect of novel docetaxel-loaded thermosensitive micelles. Eur. J. Pharm. Biopharm. 2008, 69:527-534.
16. Hwang H.Y., Kim I.S., Kwon I.C., Kim Y.H. Tumor targetability and antitumor effect of docetaxel-loaded hydrophobically modified glycol chitosan nanoparticles. J. Control. Release 2008, 128:23-31.
17. Liu Y.T., Li K., Pan J., Liu B., Feng S.S. Folic acid conjugated nanoparticles of mixed lipid monolayer shell and biodegradable polymer core for targeted delivery of Docetaxel. Biomaterials 2010, 31:330-338.
18. Bergström K., Holmberg K., Safranj A., Hoffman A.S., Edgell M.J., Kozlowski A., Hovanes B.A., Harris J.M. Reduction of fibrinogen adsorption on PEG-coated polystyrene surfaces. J. Biomed. Mater. Res. 1992, 26:779-790.
19. Bergström K., Osterberg E., Holmberg K., Hoffman A.S., Schuman T.P., Kozlowski A., Harris J.M. Effects of branching and molecular weight of surface-bound poly(ethylene oxide) on protein rejection. J. Biomater. Sci. Polym. Ed. 1994, 6:123-132.
20. Gref R., Luck M., Quellec P., Marchand M., Dellacherie E., Harnisch S., Blunk T., Muller R.H. "Stealth" corona-core nanoparticles surface modified by polyethylene glycol (PEG): influences of the corona (PEG chain length and surface density) and of the core composition on phagocytic uptake and plasma protein adsorption. Colloids Surf. B 2000, 18:301-313.
21. Sparreboom A., Zhao M., Brahmer J.R., Verweij J., Baker S.D. Determination of the docetaxel vehicle, polysorbate 80, in patient samples by liquid chromatography-tandem mass spectrometry. J. Chromatogr. B 2002, 773:183-190.
22. Wang L.Z., Goh B.C., Grigg M.E., Lee S.C., Khoo Y.M., Lee H.S. A rapid and sensitive liquid chromatography/tandem mass spectrometry method for determination of docetaxel in human plasma. Rapid Commun. Mass Spectrom. 2003, 17:1548-1552.
23. Mortier K.A., Renard V., Verstraete A.G., Van Gussem A., Van Belle S., Lambert W.E. Development and validation of a liquid chromatography-tandem mass spectrometry assay for the quantification of docetaxel and paclitaxel in human plasma and oral fluid. Anal. Chem. 2005, 77:4677-4683.
24. Huang Q., Wang G.J., Sun J.G., Hu X.L., Lu Y.H., Zhang Q. Simultaneous determination of docetaxel and ketoconazole in rat plasma by liquid chromatography/electrospray ionization tandem mass spectrometry. Rapid Commun. Mass Spectrom. 2007, 21:1009-1018.
25. Du P., Li N., Wang H.Y., Yang S., Song Y.Y., Han X.H., Shi Y.K. Development and validation of a rapid and sensitive UPLC-MS/MS method for determination of total docetaxel from a lipid microsphere formulation in human plasma. J. Chromatogr. B 2013, 926:101-107.
26. Parise R.A., Ramanathan R.K., Zamboni W.C., Egorina M.J. Sensitive liquid chromatography-mass spectrometry assay for quantitation of docetaxel and paclitaxel in human plasma. J. Chromatogr. B 2003, 783:231-236.
27. Zhao L., Wei Y.M., Zhong X.D., Liang Y., Zhang X.M., Li W., Li B.B., Wang Y., Yu Y. PK and tissue distribution of docetaxel in rabbits after i.v. administration of liposomal and injectable formulations. J. Pharm. Biomed. Anal. 2009, 49:989-996.
28. Hou W.Y., Watters J.W., McLeod H.L. Simple and rapid docetaxel assay in plasma by protein precipitation and high-performance liquid chromatography-tandem mass spectrometry. J. Chromatogr. B 2004, 804:263-267.
29. Yamaguchi H., Fujikawa A., Ito H., Tanaka N., Furugen A., Miyamori K., Takahashi N., Ogura J., Kobayashi M., Yamada T., Mano N., Iseki K. A rapid and sensitive LC/ESI-MS/MS method for quantitative analysis of docetaxel in human plasma and its application to a pharmacokinetic study. J. Chromatogr. B 2012, 893-894:157-161.
30. Guidance for Industry: Bioanalytical Method Validation (updated 2001). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf.
31. Guideline on bioanalytical method validation. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.