Validation of high-performance liquid chromatography-tandem mass spectrometry assays for the quantification of eribulin (E7389) in various biological matrices

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 879, Issue 15-16, 2011, Pages 1149-1155

  Dubbelman, A C ^a   Rosing, H ^a   Thijssen, B ^a   Lucas, L ^a   Copalu, W ^b   Wanders, J ^b   Schellens, J H M ^a,c   Beijnen, J H ^a,c  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b EISAI CO LTD   (Japan)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

E7389; Eribulin; Human mass balance study; LC MS MS

Indexed keywords

ANTI-CANCER AGENTS; BIOLOGICAL MATRIXES; CLINICAL STUDY; CONCENTRATION RANGES; CORRELATION COEFFICIENT; CV VALUE; E7389; ERIBULIN; GRADIENT ELUTION; HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; HPLC-MS/MS; HUMAN MASS BALANCE STUDY; HUMAN PLASMAS; INTERNAL STANDARDS; LC-MS/MS; LIQUID-LIQUID EXTRACTION; POSITIVE ION MODE; SAMPLE VOLUME; STABILITY ASSESSMENT; STRUCTURAL ANALOGUE; TANDEM MASS SPECTROMETRY; TRIPLE QUADRUPOLE; VALIDATION RESULTS; WHOLE BLOOD;

BLOOD; CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PLASMA STABILITY; SOLVENT EXTRACTION; SYSTEM STABILITY;

LIQUIDS;

ERIBULIN;

ACCURACY; ARTICLE; CONTROLLED STUDY; CORRELATION COEFFICIENT; DRUG BLOOD LEVEL; DRUG FECES LEVEL; DRUG STRUCTURE; DRUG URINE LEVEL; ELUTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID LIQUID EXTRACTION; PRIORITY JOURNAL; QUADRUPOLE MASS SPECTROMETRY; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

CHEMICAL FRACTIONATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; FECES; FURANS; HUMANS; KETONES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY;

EID: 79955017116     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2011.03.021     Document Type: Article

References (9)

1. U.S. Food and Drug Administration, FDA labelling information - Halaven, 2010. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf.
2. Kuznetsov G., Towle M.J., Cheng H., Kawamura T., TenDyke K., Liu D., Kishi Y., Yu M.J., Littlefield B.A. Cancer Res. 2004, 64:5760.
3. Jordan M.A., Kamath K., Manna T., Okouneva T., Miller H.P., Davis C., Littlefield B.A., Wilson L. Mol. Cancer Ther. 2005, 4:1086.
4. Vahdat L.T., Pruitt B., Fabian C.J., Rivera R.R., Smith D.A., Tan-Chiu E., Wright J., Tan A.R., Dacosta N.A., Chuang E., Smith J., O'Shaughnessy J., Shuster D.E., Meneses N.L., Chandrawansa K., Fang F., Cole P.E., Ashworth S., Blum J.L. J. Clin. Oncol. 2009, 27:2954.
5. Desjardins C., Saxton P., Lu S.X., Li X., Rowbottom C., Wong Y.N. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2008, 875:373.
6. U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry, Bioanalytical Method Validation, 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf.
7. Rosing H., Man W.Y., Doyle E., Bult A., Beijnen J.H. J. Liq. Chromatogr. Rel. Technol. 2000, 23:329.
8. Niessen W.M.A. Liquid Chromatography-Mass Spectrometry 2006, CRC Press, Taylor & Francis Group, (Chapter 1, pp. 3-22).
9. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. Pharm. Res. 2007, 24:1962.