Home Medicine A validated LC-MS/MS method for the simultaneous quantification of the novel combination antibiotic, ceftolozane–tazobactam, in plasma (total and unbound), CSF, urine and renal replacement therapy effluent: application to pilot pharmacokinetic studies
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A validated LC-MS/MS method for the simultaneous quantification of the novel combination antibiotic, ceftolozane–tazobactam, in plasma (total and unbound), CSF, urine and renal replacement therapy effluent: application to pilot pharmacokinetic studies

  • Suzanne L. Parker EMAIL logo , Saurabh Pandey , Fekade B. Sime , Janine Stuart , Jeffrey Lipman , Jason A. Roberts and Steven C. Wallis
Published/Copyright: November 25, 2020
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 5

Abstract

Objectives

Novel treatment options for some carbapenem-resistant Gram-negative pathogens have been identified by the World Health Organization as being of the highest priority. Ceftolozane–tazobactam is a novel cephalosporin–beta-lactamase inhibitor combination antibiotic with potent bactericidal activity against the most difficult-to-treat multi-drug resistant and extensively drug resistant Gram-negative pathogens. This study aimed to develop and validate a liquid chromatography – tandem mass spectrometry method for the simultaneous quantification of ceftolozane and tazobactam in plasma (total and unbound), renal replacement therapy effluent (RRTE), cerebrospinal fluid (CSF) and urine.

Methods

Analytes were separated using mixed-mode chromatography with an intrinsically base-deactivated C18 column and a gradient mobile phase consisting of 0.1% formic acid, 10 mM ammonium formate and acetonitrile. The analytes and internal standards were detected using rapid ionisation switching between positive and negative modes with simultaneous selected reaction monitoring.

Results

A quadratic calibration was obtained for plasma (total and unbound), RRTE and CSF over the concentration range of 1–200 mg/L for ceftolozane and 0.5–100 mg/L for tazobactam, and for urine the concentration range of 10–2,000 mg/L for ceftolozane and 5–1,000 mg/L for tazobactam. For both ceftolozane and tazobactam, validation testing for matrix effects, precision and accuracy, specificity and stability were all within the acceptance criteria of ±15%.

Conclusions

This methodology was successfully applied to one pilot pharmacokinetic study in infected critically ill patients, including patients receiving renal replacement therapy, and one case study of a patient with ventriculitis, where all patients received ceftolozane–tazobactam.

Keywords: antibiotic; ceftolozane; chromatography; mass spectrometry; tazobactam
Corresponding author: Suzanne L. Parker, UQ Centre for Clinical Research, The University of Queensland, Royal Brisbane and Women’s Hospital, Brisbane, QLD 4029, Australia, Phone: +61 7 33465104, E-mail:

Funding source: Merck Sharp and Dohme

  1. Research funding: This study was funded in part by an investigator-initiated grant from MSD. SLP is a recipient of a National Health and Medical Research Council-funded Fellowship (APP1142757), JAR is a recipient of a National Health and Medical Research Council-funded Centre for Research Excellence Research Excellence (APP1044941), Project Grant (1062040) and Fellowship (APP1048652).

  2. Author contributions: SLP: method design, data analysis, interpretation of results and writing of manuscript; SP: method design, data analysis, writing of manuscript; FS: study protocol design and writing of manuscript; JL: study protocol design and writing of manuscript; JAR: study protocol design and interpretation of results and writing of manuscript; SCW: method design, data interpretation and writing of manuscript.

  3. Competing interests: JAR has provided consultancy and has received grant funding from MSD. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

  4. Ethical approval: The study was performed in accordance with the ethical standards, with ethical approval obtained for the use of drug-free human blood from the Royal Brisbane and Women’s Hospital Human Research Ethics Committee HREC/16/QRBW/211and HREC/17/QRBW/117.

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Received: 2020-07-16
Accepted: 2020-11-02
Published Online: 2020-11-25
Published in Print: 2021-04-27

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2020-1196
Keywords for this article
antibiotic; ceftolozane; chromatography; mass spectrometry; tazobactam

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Home pregnancy tests: quality first
  4. Review
  5. Non-invasive determination of uric acid in human saliva in the diagnosis of serious disorders
  6. Opinion Papers
  7. Basophil counting in hematology analyzers: time to discontinue?
  8. The role of laboratory hematology between technology and professionalism: the paradigm of basophil counting
  9. Recommendations for validation testing of home pregnancy tests (HPTs) in Europe
  10. General Clinical Chemistry and Laboratory Medicine
  11. The use of preanalytical quality indicators: a Turkish preliminary survey study
  12. The Italian External Quality Assessment (EQA) program on urinary sediment by microscopy examination: a 20 years journey
  13. Non-HDL-C/TG ratio indicates significant underestimation of calculated low-density lipoprotein cholesterol (LDL-C) better than TG level: a study on the reliability of mathematical formulas used for LDL-C estimation
  14. Evaluation of the protein gap for detection of abnormal serum gammaglobulin level: an imperfect predictor
  15. Impact of routine S100B protein assay on CT scan use in children with mild traumatic brain injury
  16. Using machine learning to develop an autoverification system in a clinical biochemistry laboratory
  17. Effect of collection matrix, platelet depletion, and storage conditions on plasma extracellular vesicles and extracellular vesicle-associated miRNAs measurements
  18. Pneumatic tube transportation of urine samples
  19. Evaluation of the first immunosuppressive drug assay available on a fully automated LC-MS/MS-based clinical analyzer suggests a new era in laboratory medicine
  20. A validated LC-MS/MS method for the simultaneous quantification of the novel combination antibiotic, ceftolozane–tazobactam, in plasma (total and unbound), CSF, urine and renal replacement therapy effluent: application to pilot pharmacokinetic studies
  21. Immunosuppressant quantification in intravenous microdialysate – towards novel quasi-continuous therapeutic drug monitoring in transplanted patients
  22. Reference Values and Biological Variations
  23. Reference intervals for venous blood gas measurement in adults
  24. Cardiovascular Diseases
  25. Detection and functional characterization of a novel MEF2A variation responsible for familial dilated cardiomyopathy
  26. Diabetes
  27. Evaluation of the ARKRAY HA-8190V instrument for HbA1c
  28. Infectious Diseases
  29. An original multiplex method to assess five different SARS-CoV-2 antibodies
  30. Evaluation of dried blood spots as alternative sampling material for serological detection of anti-SARS-CoV-2 antibodies using established ELISAs
  31. Variability of cycle threshold values in an external quality assessment scheme for detection of the SARS-CoV-2 virus genome by RT-PCR
  32. The vasoactive peptide MR-pro-adrenomedullin in COVID-19 patients: an observational study
  33. Corrigenda
  34. Corrigendum to: Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals
  35. Corrigendum to: Age appropriate reference intervals for eight kidney function and injury markers in infants, children and adolescents
  36. Letters to the Editor
  37. A panhaemocytometric approach to COVID-19: a retrospective study on the importance of monocyte and neutrophil population data on Sysmex XN-series analysers
  38. Letter in reply to the letter to the editor of Harte JV and Mykytiv V with the title “A panhaemocytometric approach to COVID-19: a retrospective study on the importance of monocyte and neutrophil population data”
  39. SARS-CoV-2 serologic tests: do not forget the good laboratory practice
  40. Long-term kinetics of anti-SARS-CoV-2 antibodies in a cohort of 197 hospitalized and non-hospitalized COVID-19 patients
  41. Self-sampling at home using volumetric absorptive microsampling: coupling analytical evaluation to volunteers’ perception in the context of a large scale study
  42. Vortex mixing to alleviate pseudothrombocytopenia in a blood specimen with platelet satellitism and platelet clumps
  43. Comparative evaluation of the fully automated HemosIL® AcuStar ADAMTS13 activity assay vs. ELISA: possible interference by autoantibodies different from anti ADAMTS-13
  44. Significant interference on specific point-of-care glucose measurements due to high dose of intravenous vitamin C therapy in critically ill patients
  45. As time goes by, on that you can rely … preservation of urine samples for morphological analysis of erythrocytes and casts
  46. Stability of control materials for α-thalassemia immunochromatographic strip test
  47. Reformulated Architect® cyclosporine CMIA assay: improved imprecision, worse comparability between methods
  48. Urine-to-plasma contamination mimicking acute kidney injury: small drops with major consequences
  49. Automated Mindray CL-1200i chemiluminescent assays of renin and aldosterone for the diagnosis of primary aldosteronism
  50. Use of common reference intervals does not necessarily allow inter-method numerical result trending
  51. Reply to Dr Hawkins regarding comparability of results for monitoring
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