A liquid chromatography-tandemmass spectrometry method for the simultaneous determination of exemestane and its metabolite 17-dihydroexemestane in human plasma

Journal of Mass Spectrometry

Volumn 44, Issue 6, 2009, Pages 920-928

  Corona, Giuseppe ^a   Elia, Caterina ^a   Casetta, Bruno ^b   Diana, Crivellari ^a   Rosalen, Sara ^a   Bari, Mario ^c   Toffoli, Giuseppe ^a  

^a CENTRO DI RIFERIMENTO ONCOLOGICO   (Italy)

^b Applied Biosystems   (Italy)

^c PF Calvi Civic Hospital   (Italy)

Author keywords

17 dihydroexemestane; Electrospray ionization; Exemestane; Liquid chromatography; Pharmacokinetics; Tandem mass spectroscopy

Indexed keywords

17-DIHYDROEXEMESTANE; ADJUVANT THERAPY; ANALYTES; ANALYTICAL METHOD; BREAST CANCER; EXEMESTANE; HUMAN PLASMAS; INTER-ASSAY PRECISION; INTERNAL STANDARDS; ION TRANSITION; ISOCRATIC; LC-MS/MS; LOWER LIMIT OF QUANTITATIONS; MULTIPLE-REACTION MONITORING MODES; PHENYL COLUMNS; POSITIVE ELECTROSPRAY IONIZATION; PROTEIN PRECIPITATION; RUNTIME; SENSITIVE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; SIMULTANEOUS DETERMINATIONS; TANDEM MASS SPECTROSCOPY; TANDEM-MASS SPECTROMETRY;

ACETONITRILE; BIOMOLECULES; CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; HIGH PRESSURE LIQUID CHROMATOGRAPHY; IONIZATION; LIQUIDS; MASS SPECTROMETERS; MASS SPECTROMETRY; METABOLISM; METABOLITES; PHARMACOKINETICS; PLASMA (HUMAN); PLASMAS;

ELECTROSPRAY IONIZATION;

17 DIHYDROEXEMESTANE; ACETONITRILE; DRUG METABOLITE; EXEMESTANE; STABLE ISOTOPE; UNCLASSIFIED DRUG; 17-DIHYDROEXEMESTANE; ANDROSTANE DERIVATIVE; ANTINEOPLASTIC AGENT;

ACCURACY; AREA UNDER THE CURVE; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CHEMICAL REACTION; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DEGRADATION; DRUG HALF LIFE; DRUG STABILITY; ELECTROSPRAY MASS SPECTROMETRY; ELUTION; HUMAN; LIQUID CHROMATOGRAPHY; MONITORING; PLASMA; PRECIPITATION; PRIORITY JOURNAL; PROCESS OPTIMIZATION; TANDEM MASS SPECTROMETRY; THERMOSTABILITY; BLOOD; ECONOMICS; ISOLATION AND PURIFICATION; METABOLISM; METHODOLOGY; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; TIME; VALIDATION STUDY;

ANDROSTADIENES; ANTINEOPLASTIC AGENTS; CHROMATOGRAPHY, LIQUID; HUMANS; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; TANDEM MASS SPECTROMETRY; TIME FACTORS;

EID: 67649158224     PISSN: 10765174     EISSN: 10969888     Source Type: Journal    
DOI: 10.1002/jms.1566     Document Type: Article

References (17)

1. P. E. Lonning, J. Geisler. Experience with exemestane in the treatment of early and advanced breast cancer. Expert Opinion on Drug Metabolism and Toxicology 2008, 4, 987.
2. E. di Salle, G. Ornati, D. Giudici, M. Lassus, T. R. Evans, R. C. Coombes. Exemestane (FCE 24304), a new steroidal aromatase inhibitor. Journal of Steroid Biochemistry and Molecular Biology 1992, 43, 137.
3. J. Geisler, N. King, G. Anker, G. Ornati, E. di Salle, P. E. Lonning, M. Dowsett. In vivo inhibition of aromatization by exemestane, a novel irreversible aromatase inhibitor, in postmenopausal breast cancer patients. Clinical Cancer Research 1998, 4, 2089.
4. R. C. Coombes, L. S. Kilburn, C. F. Snowdon, R. Paridaens, R. E. Coleman, S. E. Jones, J. Jassem, C. J. Van de Velde, T. Delozier, I. Alvarez, L. Del Mastro, O. Ortmann, K. Diedrich, A. S. Coates, E. Bajetta, S. B. Holmberg, D. Dodwell, E. Mickiewicz, J. Andersen, P. E. Lonning, G. Cocconi, J. Forbes, M. Castiglione, N. Stuart, A. Stewart, L. J. Fallowfield, G. Bertelli, E. Hall, R. G. Bogle, M. Carpentieri, E. Colajori, M. Subar, E. Ireland, J. M. Bliss. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007, 369, 559.
5. P. E. Lonning, J. Geisler, L. E. Krag, B. Erikstein, Y. Bremnes, A. I. Hagen, E. Schlichting, E. A. Lien, E. S. Ofjord, J. Paolini, A. Polli, G. Massimini. Effects of exemestane administered for 2 years versus placebo on bone mineral density, bone biomarkers, and plasma lipids inpatients with surgically resected early breast cancer. Journal of Clinical Oncology 2005, 23, 5126.
6. E. A. Ariazi, A. Leitao, T. I. Oprea, B. Chen, T. Louis, A. M. Bertucci, C. G. Sharma, S. D. Gill, H. R. Kim, H. A. Shupp, J. R. Pyle, A. Madrack, A. L. Donato, D. Cheng, J. R. Paige, V. C. Jordan. Exemestane's 17- hydroxylated metabolite exerts biological effects as an androgen. Molecular Cancer Therapeutics 2007, 6, 2817.
7. P. A. Canney, M. A. Machin, J. Curto. A feasibility study of the efficacy and tolerability of the combination of Exemestane with the COX-2 inhibitor Celecoxib in post-menopausal patients with advanced breast cancer. European Journal of Cancer 2006, 42, 2751.
8. A. Leary, M. Dowsett. Combination therapy with aromatase inhibitors: the next era of breast cancer treatment. British Journal of Cancer 2006, 95, 661.
9. M. Breda, E. Pianezzola, M. S. Benedetti. Determination of exemestane, a new aromatase inhibitor, in plasma by high-performance liquid chromatography with ultraviolet detection. Journal of Chromatography 1993, 620, 225.
10. S. Persiani, F. Broutin, P. Cicioni, P. Stefanini, M. S. Benedetti. Determination of the new aromatase inhibitor exemestane in biological fluids by automated high-performance liquid chromatography followed by radioimmunoassay. European Journal of Pharmaceutical Sciences 1996, 4, 331.
11. V. Cenacchi, S. Baratte, P. Cicioni, E. Frigerio, J. Long, C. James. LCMS- MS determination of exemestane in human plasmawith heated nebulizer interface following solid-phase extraction in the 96 well plate format. Journal of Pharmaceutical and Biomedical Analysis 2000, 22, 451.
12. E. Rivera, V. Valero, D. Francis, A. G. Asnis, L. J. Schaaf, B. Duncan, G. N. Hortobagyi. Pilot study evaluating the pharmacokinetics, pharmacodynamics, and safety of the combination of exemestane and tamoxifen. Clinical Cancer Research 2004, 10, 1943.
13. U. Mareck, H. Geyer, S. Guddat, N. Haenelt, A. Koch, M. Kohler, G. Opfermann, M. Thevis, W. Schanzer. Identification of the aromatase inhibitors anastrozole and exemestane in human urine using liquid chromatography/tandem mass spectrometry. Rapid Communications in Mass Spectrometry 2006, 20, 1954.
14. US Food and Drug Administration Cencer for Drug Evaluation and Eesearch. 2001, Guidance for the Industry: Bioanalytical method validation, US Food and Drug Administration, http://www.fda.gov/CDER/GUIDANCE/4252fnl.htm.
15. M. Thevis, W. Schanzer. Mass spectrometric analysis of androstan- 17beta-ol-3-one and androstadiene-17beta-ol-3-one isomers. Journal of the American Society for Mass Spectrometry 2005, 16, 1660.
16. Z. Yan, N. Maher, R. Torres, C. Cotto, B. Hastings, M. Dasgupta, R. Hyman, N. Huebert, G. W. Caldwell. Isobaric metabolite interferences and the requirement for close examination of raw data in addition to stringent chromatographic separations in liquid chromatography/tandem mass spectrometric analysis of drugs in biological matrix. Rapid Communications in Mass Spectrometry 2008, 22, 2021.
17. M. G. Jannuzzo, I. Poggesi, R. Spinelli, M. Rocchetti, P. Cicioni, P. Buchan. The effects of degree of hepatic or renal impairment on the pharmacokinetics of exemestane in postmenopausal women. Cancer Chemotherapy and Pharmacology 2004, 53, 475.