A validated method for the quantification of fosfomycin on dried plasma spots by HPLC-MS/MS: application to a pilot pharmacokinetic study in humans

J Pharm Biomed Anal. 2015 Nov 10:115:509-14. doi: 10.1016/j.jpba.2015.07.013. Epub 2015 Jul 19.

Abstract

Quantification of fosfomycin in the plasma samples of patients is the basis of clinical pharmacokinetic studies from which evidence based dosing regimens can be devised to maximise antibiotic effectiveness against a pathogen. We have developed and validated a LC-MS/MS method to quantify fosfomycin using dried plasma spot sampling. Following HILIC chromatography, fosfomycin and ethylphosphonic acid, used as internal standard, were measured using negative-ion multiple reaction monitoring. The method was linear over the calibration range of 5-2000mg/L of fosfomycin. Intra-day assay results for dried plasma spot quality control samples at 15.6, 79.9 and 1581mg/L of fosfomycin had precision of ±4.2, 8.2, and 2.0%, respectively, and accuracy of +3.9, -0.1, and -1.2%, respectively. Recovery of fosfomycin from dried plasma spots was calculated as 83.6% and the dried plasma spot samples were found to be stable stored at room temperature for three months and when stored for four hours at 50°C. A Bland-Altman plot comparing DPS to plasma sampling found a negative bias of 16.6%, with all but one sample within the mean limits of agreement (-2.6 to 30.6%). Dried plasma spot sampling provides a useful tool for pharmacokinetic research of fosfomycin.

Keywords: Antibiotic; Dried plasma spots; Fosfomycin; LC–MS/MS; Pharmacokinetic.

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

  • Administration, Intravenous
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / blood*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Calibration
  • Chromatography, High Pressure Liquid* / standards
  • Dried Blood Spot Testing / methods*
  • Dried Blood Spot Testing / standards
  • Drug Administration Schedule
  • Drug Monitoring / methods*
  • Drug Monitoring / standards
  • Drug Stability
  • Fosfomycin / administration & dosage
  • Fosfomycin / blood*
  • Fosfomycin / pharmacokinetics*
  • Humans
  • Limit of Detection
  • Linear Models
  • Pilot Projects
  • Reference Standards
  • Reproducibility of Results
  • Tandem Mass Spectrometry* / standards
  • Temperature

Substances

  • Anti-Bacterial Agents
  • Fosfomycin