Microdialysis combined with liquid chromatography-tandem mass spectrometry for the quantitation of gemifloxacin and its application to a muscle penetration study in healthy and MRSA-infected rats

PLoS One. 2019 Jun 6;14(6):e0217573. doi: 10.1371/journal.pone.0217573. eCollection 2019.

Abstract

Pharmacological efficacy is based on the drug concentration in target tissues, which usually cannot be represented by the plasma concentration. The purpose of this study was to compare the pharmacokinetic characteristics of gemifloxacin in plasma and skeletal muscle and evaluate its tissue penetration in both healthy and MRSA (methicillin-resistant Staphylococcus aureus)-infected rats. A microdialysis (MD) combined with liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated to determine free gemifloxacin concentrations in rat plasma and skeletal muscle simultaneously. The in vivo recoveries of MD were 23.21% ± 3.42% for skeletal muscle and 20.62% ± 3.19% for plasma, and were concentration independent. We provided evidence that the method developed here meets FDA requirements. Additionally, this method was successfully applied to the determination of free gemifloxacin in rats. Muscle and blood dialysates were collected after an 18 mg/kg intravenous bolus dose. The mean areas under the concentration-time curves (AUCs) from 0 to 9 h for skeletal muscle and plasma were 3641.50 ± 915.65 h*ng/mL and 7068.32 ± 1964.19 h*ng/mL in MRSA-infected rats and 3774.72 ± 700.36 h*ng/mL and 6927.49 ± 1714.86 h*ng/mL in healthy rats, respectively. There was no significant difference (P>0.05) in gemifloxacin exposure between healthy rats and MRSA-infected rats for plasma or muscle. The low ratio of AUC0-9 muscle to AUC0-9 plasma suggested lower drug exposure in skeletal muscle than in plasma for both healthy and MRSA-infected rats. Our study suggested that the administration of gemifloxacin according to drug levels in plasma to treat local infection is unreasonable and might result in an inadequate dose regimen.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Blood Proteins / metabolism
  • Chromatography, Liquid
  • Ciprofloxacin / chemistry
  • Ciprofloxacin / pharmacology
  • Disease Models, Animal
  • Gemifloxacin / analysis*
  • Gemifloxacin / chemistry
  • Gemifloxacin / pharmacokinetics
  • Gemifloxacin / pharmacology*
  • Male
  • Methicillin-Resistant Staphylococcus aureus / drug effects*
  • Microdialysis*
  • Muscles / drug effects*
  • Muscles / microbiology*
  • Protein Binding
  • Rats, Sprague-Dawley
  • Reproducibility of Results
  • Tandem Mass Spectrometry*
  • Thigh / microbiology
  • Tissue Distribution

Substances

  • Blood Proteins
  • Ciprofloxacin
  • Gemifloxacin

Grants and funding

This study was supported by the National Natural Science Foundation of China (http://www.nsfc.gov.cn/, 81621064 and 81361138020 received by XFY), Beijing Science and Technology Projects (http://kw.beijing.gov.cn/, Z141102004414065 and Z151100000315029 received by XFY), CAMS Initiative for Innovative Medicine (http://www.pumc.edu.cn/%E9%A6%96%E9%A1%B5/, 2016-I2M-3-014 received by XFY, 2017-I2M-1-012 received by JP, and 2016-I2M-2-002 received by XW). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.