Simple and sensitive liquid chromatographic quantitative analysis of the novel marine anticancer drug Yondelis™ (ET-743, trabectedin) in human plasma using column switching and tandem mass spectrometric detection

Journal of Mass Spectrometry

Volumn 39, Issue 4, 2004, Pages 431-436

  Stokvis, E ^a   Rosing, H ^a   Lopez Lazaro L ^b   Beijnen, J H ^a,c  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b PHARMAMAR S A   (Spain)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Bioanalysis; Column switching; ET 743; Liquid Chromatography Tandem mass spectrometry; Yondelis

Indexed keywords

DRUG PRODUCTS; LIQUID CHROMATOGRAPHY; MASS SPECTROMETERS; METHANOL; ONCOLOGY; PRECIPITATION (CHEMICAL); SWITCHING;

ANTICANCER DRUGS; COLUMN SWITCHING; HUMAN PLASMAS;

MASS SPECTROMETRY;

ANTINEOPLASTIC AGENT; DEUTERIUM; METHANOL; TRABECTEDIN;

ANALYTIC METHOD; ANALYTICAL PARAMETERS; ARTICLE; CLINICAL TRIAL; COLUMN CHROMATOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DILUTION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG STRUCTURE; DYNAMICS; FOOD AND DRUG ADMINISTRATION; HUMAN; LINEAR SYSTEM; LIQUID CHROMATOGRAPHY; ONLINE SYSTEM; PHASE 2 CLINICAL TRIAL; PRECIPITATION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SENSITIVITY ANALYSIS; SEPARATION TECHNIQUE; SOLID PHASE EXTRACTION; STANDARD; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

ANTINEOPLASTIC AGENTS, ALKYLATING; CALIBRATION; CHROMATOGRAPHY, LIQUID; CLINICAL TRIALS, PHASE II; DIOXOLES; HUMANS; ISOQUINOLINES; MASS SPECTROMETRY; MOLECULAR STRUCTURE; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TETRAHYDROISOQUINOLINES;

EID: 1942516814     PISSN: 10765174     EISSN: None     Source Type: Journal    
DOI: 10.1002/jms.608     Document Type: Article

References (16)

1. van Kesteren Ch, de Vooght MMM, López-Lázaro L, Mathôt RAA, Schellens JHM, Jimeno J, Beijnen JH. Yondelis® (Trabectedin, ET-743): the development of an anticancer agent of marine origin. Anti-Cancer Drugs 2003; 14: 487.
2. Rosing H, Hillebrand MJX, Jimeno JM, Gomez A, Floriano P, Faircloth G, Henrar REC, Vermorken JB, Cvitkovic E, Bult A, Beijnen JH. Quantitative determination of ecteinascidin 743 in human plasma by miniaturized high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry. J. Mass Spectrom. 1998; 33: 1134.
3. Villalona-Calero MA, Eckhardt SG, Weiss G, Hidalgo M, Beijnen JH, van Kesteren Ch, Rosing H, Campbell E, Kraynak M, Ló pez-Lázaro L, Guzman C, Von Hoff DD, Jimeno J, Rowinsky EK. A phase I and pharmacokinetic study of ecteinascidin-743 on a daily × 5 schedule in patients with solid malignancies. Clin. Cancer Res. 2002; 8: 75.
4. Davies ID, Allanson JP, Causon RC. Rapid determination of the anti-cancer drug chlorambuil (Leukeran™) and its phenyl acetic acid mustard metabolite in human serum and plasma by automated solid-phase extraction and liquid chromatography - tandem mass spectrometry. J. Chromatogr. B 1999; 732: 173.
5. DePuy ME, Musson DG, Yu S, Fisher AL. LC-MS/MS determination of a farnesyl transferase inhibitor in human plasma and urine. J. Pharm. Biomed. Anal. 2002; 30: 1157.
6. Steinborner S, Henion J. Liquid-liquid extraction in the 96-well plate format with SRM LC/MS quantitative determination of methotrexate and its major metabolite in human plasma. Anal. Chem. 1999; 71: 2340.
7. Cenacchi V, Barattè S, Cicioni P, Frigerio E, Long J, James C. LC-MS-MS determination of exemestane in human plasma with heated nebulizer interface following solid-phase extraction in the 96 well plate format. J. Pharm. Biomed. Anal. 2000; 22: 451.
8. Kurita A, Kaneda N. High-performance liquid chromatographic method for the simultaneous determination of the camptothecin derivative irinotecan hydrochloride, CPT-11, and its metabolites SN-38 and SN-38 glucuronide in rat plasma with a fully automated on-line solid-phase extraction system, PROSPEKT. J. Chromatogr. B 1999; 724: 335.
9. Hedenmo M, Eriksson BM. On-line solid-phase extraction with automated cartridge exchange for liquid chromatographic determination of lipophilic antioxidants in plasma. J. Chromatogr. A 1994; 661: 153.
10. Brignol N, Bakhtiar R, Dou L, Majumdar T, Tse FL. Quantitative analysis of terbinafine (Lamisil) in human and minipig plasma by liquid chromatography tandem mass spectrometry. Rapid Commun. Mass Spectrom. 2000; 14: 141.
11. Ayrton J, Dear GJ, Leavens WJ, Mallett DN, Plumb RS. The use of turbulent flow chromatography/mass spectrometry for the rapid, direct analysis of a novel pharmaceutical compound in plasma. Rapid Communi. Mass Spectrom. 1997; 11: 1935.
12. Haginaka J, Sanbe H. Uniform-sized molecularly imprinted polymers for 2-arylpropionic acid derivatives selectively modified with hydrophilic external layer and their applications to direct serum injection analysis. Anal. Chem. 2000; 72: 5206.
13. Zell M, Husser C, Erdin R, Hopfgartner G. Simultaneous determination of a potassium channel opener and its metabolite in rat plasma with column-switching liquid chromatography using atmospheric pressure chemical ionisation. J. Chromatogr. B 1997; 694: 135.
14. Gao VC, Luo WC, Ye Q, Thoolen M. Column switching in high-performance liquid chromatography with tandem mass spectrometric detection for high-throughput preclinical pharmacokinetic studies. J. Chromatogr. A 1998; 828: 141.
15. Breda M, Basileo G, Fonte G, Long J, James CA. Determination of 4-demethoxy-3′-deamino-3′-aziridinyl-4′ -methylsulphonyldaunorubicin and its 13-hydroxy metabolite by direct injection of human plasma into a column-switching liquid chromatography system with mass spectrometric detection. J. Chromatogr. A 1999; 854: 81.
16. US Food and Drug Administration: Center for Drug Evaluation and Research. Guidance for Industry: Bioanalytical Method Validation. 2001; ww.fda.gov/cder/guidance/4252fnl.htm.