Quantification and validation of ertapenem using a liquid chromatography-tandem mass spectrometry method

Antimicrobial Agents and Chemotherapy

Volumn 58, Issue 6, 2014, Pages 3481-3484

  Van Rijn, S P ^a   Wessels, A M A ^a   Greijdanus, B ^a   Touw, D J ^a   Alffenaar, J W C ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ERTAPENEM; ANTIINFECTIVE AGENT; BETA LACTAM;

ACCURACY; ARTICLE; CALIBRATION; CONCENTRATION (PARAMETERS); DRUG BLOOD LEVEL; FREEZE THAWING; HUMAN; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETER; PRIORITY JOURNAL; ROOM TEMPERATURE; TANDEM MASS SPECTROMETRY; VALIDATION STUDY; BLOOD; CHEMISTRY; DRUG MONITORING; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PROCEDURES; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY;

ANTI-BACTERIAL AGENTS; BETA-LACTAMS; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG MONITORING; DRUG STABILITY; HUMANS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY;

EID: 84901258753     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00025-14     Document Type: Article

References (21)

1. Hugonnet JE, Tremblay LW, Boshoff HI, Barry CE, III, Blanchard JS. 2009. Meropenem-clavulanate is effective against extensively drugresistant Mycobacterium tuberculosis. Science 323:1215-1218. http://dx.doi.org/10.1126/ science.1167498.
2. Gupta R, Lavollay M, Mainardi JL, Arthur M, Bishai WR, Lamichhane G. 2010. The Mycobacterium tuberculosis protein LdtMt2 is a nonclassical transpeptidase required for virulence and resistance to amoxicillin. Nat. Med. 16:466-469. http://dx.doi.org/10.1038/nm.2120.
3. Majumdar AK, Musson DG, Birk KL, Kitchen CJ, Holland S, McCrea J, Mistry G, Hesney M, Xi L, Li SX, Haesen R, Blum RA, Lins RL, Greenberg H, Waldman S, Deutsch P, Rogers JD. 2002. Pharmacokinetics of ertapenem in healthy young volunteers. Antimicrob. Agents Chemother. 46:3506-3511.
4. Nicolau DP. 2008. Pharmacokinetic and pharmacodynamic properties of meropenem. Clin. Infect. Dis. 47(Suppl 1):S32-S40. http://dx.doi.org/10.1086/ 590064.
5. Burkhardt O, Kumar V, Schmidt S, Kielstein JT, Welte T, Derendorf H. 2010. Underdosing of ertapenem in critically ill patients with pneumonia confirmed by Monte Carlo simulations. Int. J. Antimicrob. Agents. 35:96-97. http://dx.doi.org/10.1016/j.ijantimicag.2009.09.007.
6. Brink AJ, Richards GA, Schillack V, Kiem S, Schentag J. 2009. Pharmacokinetics of once-daily dosing of ertapenem in critically ill patients with severe sepsis. Int. J. Antimicrob. Agents. 33:432-436. http://dx.doi.org/ 10.1016/j.ijantimicag.2008.10.005.
7. Dailly E, Arnould JF, Fraissinet F, Naux E, Letard de la Bouraliere MA, Bouquie R, Deslandes G, Jolliet P, Le Floch R. 2013. Pharmacokinetics of ertapenem in burns patients. Int. J. Antimicrob. Agents. 42:48-52. http://dx.doi.org/10.1016/j.ijantimicag.2013.02.021.
8. Chen M, Nafziger AN, Drusano GL, Ma L, Bertino JS, Jr. 2006 Comparative pharmacokinetics and pharmacodynamic target attainment of ertapenem in normal-weight, obese, and extremely obese adults. Antimicrob. Agents Chemother. 50:1222-1227. http://dx.doi.org/10.1128/AAC.50.4.1222-1227.2006.
9. Mistry GC, Majumdar AK, Swan S, Sica D, Fisher A, Xu Y, Hesney M, Xi L, Wagner JA, Deutsch PJ. 2006. Pharmacokinetics of ertapenem in patients with varying degrees of renal insufficiency and in patients on hemodialysis. J. Clin. Pharmacol. 46:1128-1138. http://dx.doi.org/10.1177/0091270006291839.
10. Abdel-Rahman SM, Kearns GL, Topelberg S, Jacobs RF, Mistry GC, Majumdar A, Xu Y, Wagner JA, Kitchen CJ, Groff M, Herman G, Blumer JL. 2010. Pharmacokinetics and tolerability of single-dose intravenous ertapenem in infants, children, and adolescents. Pediatr. Infect. Dis. J. 29:1072-1076. http://dx.doi.org/10.1097/INF.0b013e3181e82608.
11. Wiskirchen DE, Housman ST, Quintiliani R, Nicolau DP, Kuti JL. 2013. Comparative pharmacokinetics, pharmacodynamics, and tolerability of ertapenem 1 gram/day administered as a rapid 5-minute infusion versus the standard 30-minute infusion in healthy adult volunteers. Pharmacotherapy 33:266-274. http://dx.doi.org/10.1002/phar.1197.
12. Breilh D, Fleureau C, Gordien JB, Joanes-Boyau O, Texier-Maugein J, Rapaport S, Boselli E, Janvier G, Saux MC. 2011. Pharmacokinetics of free ertapenem in critically ill septic patients: intermittent versus continuous infusion. Minerva Anestesiol. 77:1058-1062.
13. Caminero JA, Sotgiu G, Zumla A, Migliori GB. 2010. Best drug treatment for multidrug-resistant and extensively drug-resistant tuberculosis. Lancet Infect. Dis. 10:621-629. http://dx.doi.org/10.1016/S1473-3099(10) 70139-0.
14. De Lorenzo S, Alffenaar JW, Sotgiu G, Centis R, D'Ambrosio L, Tiberi S, Bolhuis MS, van Altena R, Viggiani P, Piana A, Spanevello A, Migliori GB. 2012. Efficacy and safety of meropenem/clavulanate added to linezolid containing regimens in the treatment of M/XDR-TB. Eur. Respir. J. 41:1386-1392. http://dx.doi.org/10.1183/09031936.00124312.
15. Dauby N, Muylle I, Mouchet F, Sergysels R, Payen MC. 2011. Meropenem/ clavulanate and linezolid treatment for extensively drug-resistant tuberculosis. Pediatr. Infect. Dis. J. 30:812-813. http://dx.doi.org/10.1097/INF. 0b013e3182154b05.
16. Payen MC, De Wit S, Martin C, Sergysels R, Muylle I, Van Laethem Y, Clumeck N. 2012. Clinical use of the meropenem-clavulanate combination for extensively drug-resistant tuberculosis. Int. J. Tuberc. Lung Dis. 16:558-560. http://dx.doi.org/10.5588/ijtld.11.0414.
17. Koal T, Deters M, Resch K, Kaever V. 2006. Quantification of the carbapenem antibiotic ertapenem in human plasma by a validated liquid chromatography-mass spectrometry method. Clin. Chim. Acta 364:239-245. http://dx.doi.org/10.1016/j.cccn.2005.07.004.
18. Pickering M, Brown S. 2013. Quantification and validation of HPLC-UV and LC-MS assays for therapeutic drug monitoring of ertapenem in human plasma. Biomed. Chromatogr. 27:568-574. http://dx.doi.org/10.1002/bmc.2829.
19. Lowes S, Jersey J, Shoup R, Garofolo F, Savoie N, Mortz E, Needham S, Caturla MC, Steffen R, Sheldon C, Hayes R, Samuels T, Di Donato L, Kamerud J, Michael S, Lin ZJ, Hillier J, Moussallie M, de Souza Teixeira L, Rocci M, Buonarati M, Truog J, Hussain S, Lundberg R, Breau A, Zhang T, Jonker J, Berger N, Gagnon-Carignan S, Nehls C, Nicholson R, Hilhorst M, Karnik S, de Boer T, Houghton R, Smith K, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Vija J, Malone M, Heller D. 2011. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis. Bioanalysis 3:1323-1332. http://dx.doi.org/10.4155/bio.11.135.
20. U.S. Department of Health and Human Services Food and Drug Administration. 2001. Guidance for industry, bioanalytical method validation. Center for Drug Evaluation and Research, Rockville, MD.
21. European Medicines Agency, Committee for Medicinal Products for Human Use. 2011. Guideline on bioanalytical validation (EMEA/ CHMP/EWP/192217/2009). European Medicines Agency, London, United Kingdom.