Development of a rapid LC-MS/MS method for simultaneous quantification of ten commonly used antibiotic drugs in human serum

J Pharm Biomed Anal. 2024 Jul 15:244:116119. doi: 10.1016/j.jpba.2024.116119. Epub 2024 Mar 30.

Abstract

The use of TDM in clinical practice to monitor the plasma levels of antibiotics administered to critically ill patients is a well-established approach that allows for optimization of the patient's response to drug therapy, considering the characteristics of the drug, the clinical and physiological status of the patient and any peculiar of the pathogen that caused the clinical picture. In our laboratory, we have developed a single LC-MS/MS analysis for dosing the serum concentration of an antibacterial panel composed of eight antibacterial and two selective inhibitors. The method presented used a certified material furnished by a commercial company and was internally validated using the EMA guidelines. The results have shown high sensitivity, precision, and accuracy, a lower matrix effect combined with simple sample preparation and a time-saving procedure. We have evaluated the recovery rate and matrix effect by testing serum samples without pathological index and serum pools obtained from haemolysed, icteric, or lipemic samples. The assay has shown a recovery range between 94% and 101%.

Keywords: Antibiotics; Internal validation; LC-MS/MS; Real-time TDM.

MeSH terms

  • Anti-Bacterial Agents* / blood
  • Chromatography, High Pressure Liquid / methods
  • Chromatography, Liquid / methods
  • Drug Monitoring* / methods
  • Humans
  • Liquid Chromatography-Mass Spectrometry
  • Reproducibility of Results
  • Tandem Mass Spectrometry* / methods

Substances

  • Anti-Bacterial Agents