Development and validation of an ultra performance liquid chromatography-tandem mass spectrometry method for the quantification of daptomycin in human plasma

Journal of Pharmaceutical and Biomedical Analysis

Volumn 56, Issue 1, 2011, Pages 78-85

  Bazoti, Fotini N ^a   Gikas, Evangelos ^b   Skoutelis, Athanasios ^c   Tsarbopoulos, Anthony ^a,d  

^a Goulandris Natural History Museum   (Greece)

^b UNIVERSITY OF ATHENS   (Greece)

^c EVANGELISMOS HOSPITAL   (Greece)

^d UNIVERSITY OF PATRAS   (Greece)

Author keywords

Daptomycin; Human plasma; Quantification; Tandem mass spectrometry; Ultra performance liquid chromatography; Validation

Indexed keywords

ACETONITRILE; DAPTOMYCIN; FORMIC ACID; RESERPINE;

ACCURACY; ARTICLE; BLOOD SAMPLING; CHROMATOGRAPHY; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG STRUCTURE; ELECTROSPRAY MASS SPECTROMETRY; HUMAN; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; OSTEOMYELITIS; PLASMA VOLUME; PRIORITY JOURNAL; SENSITIVITY ANALYSIS; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

ANTI-BACTERIAL AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DAPTOMYCIN; HUMANS; LIMIT OF DETECTION; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; MOLECULAR STRUCTURE; OSTEOMYELITIS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; TANDEM MASS SPECTROMETRY;

EID: 79958039185     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.04.019     Document Type: Article

References (23)

1. Johnson A. Daptomycin in the treatment of skin, soft-tissue and invasive infections due to Gram-positive bacteria. Future Microbiol. 2006, 1:255-265.
2. Marco F., de la Mària C.G., Armero Y., Amat E., Soy D., Moreno A., del Río A., Almela M., Mestres C.A., Gatell J.M., Jiménez de Anta M.T., Miró J.M. Daptomycin is effective in treatment of experimental endocarditis due to methicillin-resistant and glycopeptide-intermediate Staphylococcus aureus. Antimicrob. Agents Chemother. 2008, 52:2538-2543. Hospital Clinic Experimental Endocarditis Study Group.
3. Eliopoulos G.M., Willey S., Reiszner E., Spitzer P.G., Caputo G., Moellering R.C. In vitro and in vivo activity of LY 146032, a new cyclic lipopeptide antibiotic. Antimicrob. Agents Chemother. 1986, 30:532-535.
4. Cottagnoud P. Daptomycin: a new treatment for insidious infections due to gram-positive pathogens. Swiss Med. Wkly. 2008, 138:93-99.
5. Demain A.L. Antibiotics: natural products essential to human health. Med. Res. Rev. 2009, 29:821-842.
6. FDA, Drug Approvals and Databases, Drug Approval Package: Cubicin. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-572_Cubicin.cfm.
7. Raja A., LaBonte J., Lebbos J., Kirkpatrick P. Daptomycin. Nat. Rev. Drug Discov. 2003, 2:943-944.
8. Dvorchik B.H., Brazier D., DeBruin M.F., Arbeit R.D. Daptomycin pharmacokinetics and safety following administration of escalating doses once daily to healthy subjects. Antimicrob. Agents Chemother. 2003, 47:1318-1323.
9. Tobin C.M., Darville J.M., Lovering A.M., Macgowan A.P. An HPLC assay for daptomycin in serum. J. Antimicrob. Chemother. 2008, 62:1462-1463.
10. Martens-Lobenhoffer J., Kielstein J.T., Oye C., Bode-Böger S.M. Validated high performance liquid chromatography-UV detection method for the determination of daptomycin in human plasma. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2008, 875:546-550.
11. Mohr J.F., Ostrosky-Zeichner L., Wainright D.J., Parks D.H., Hollenbeck T.C., Ericsson C.D. Pharmacokinetic evaluation of single-dose intravenous daptomycin in patients with thermal burn injury. Antimicrob. Agents Chemother. 2008, 52:1891-1893.
12. Dvorchik B.H. Moderate liver impairment has no influence on daptomycin pharmacokinetics. J. Clin. Pharmacol. 2004, 44:715-722.
13. Huang V., Rybak M.J. Evaluation of daptomycin activity against Staphylococcus aureus in an in vitro pharmacodynamic model under normal and simulated impaired renal function. J. Antimicrob. Chemother. 2006, 57:116-121.
14. Gikas E., Bazoti F.N., Fanourgiakis P., Perivolioti E., Roussidis A., Skoutelis A., Tsarbopoulos A. Development and validation of a UPLC-UV method for the determination of daptomycin in rabbit plasma. Biomed. Chromatogr. 2010, 24:522-527.
15. Gikas E., Bazoti F.N., Fanourgiakis P., Perivolioti E., Roussidis A., Skoutelis A., Tsarbopoulos A. Simultaneous quantification of daptomycin and rifampicin in plasma by ultra performance liquid chromatography: application to a pharmacokinetic study. J. Pharm. Biomed. Anal. 2010, 51:901-906.
16. Gika H.G., Michopoulos F., Divanis D., Metalidis S., Nikolaidis P., Theodoridis G.A. Daptomycin determination by liquid chromatography-mass spectrometry in peritoneal fluid, blood plasma, and urine of clinical patients receiving peritoneal dialysis treatment. Anal. Bioanal. Chem. 2010, 397:2191-2197.
17. Verdier M.-C., Bentue-Ferrer D., Tribut O., Collet N., Revest M., Bellissant E. Determination of daptomycin in human plasma by liquid chromatography-tandem mass spectrometry. Clinical application. Clin. Chem. Lab. Med. 2011, 49:69-75.
18. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), May 2001. http://www.fda.gov/cder/guidance/indes.htm.
19. European Medicines Agency, Committee for Medicinal Products For Human Use (CHMP), Guideline on Validation of Bioanalytical Methods, Doc. Ref: EMEA/CHMP/EWP/192217/2009.
20. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures, Text and Methodology Q2(R1), 2005.
21. Beaudry F., Vachon P. Electrospray ionization suppression, a physical or a chemical phenomenon?. Biomed. Chromatogr. 2006, 20:200-205.
22. Annesley T.M. Ion suppression in mass spectrometry. Clin. Chem. 2003, 49:1041-1044.
23. Sangster T., Spence M., Sinclair P., Payne R., Smith C. Unexpected observation of ion suppression in a liquid chromatography/atmospheric pressure chemical ionization mass spectrometric bioanalytical method. Rapid Commun. Mass Spectrom. 2004, 18:1361-1364.