Analytical Quality by Design-based development and validation of ultra pressure liquid chromatography/MS/MS method for glycopeptide antibiotics determination in human plasma

Bioanalysis. 2018 Nov 1;10(22):1861-1876. doi: 10.4155/bio-2018-0181. Epub 2018 Nov 6.

Abstract

Aim: An ultra pressure liquid chromatography (UPLC)/MS/MS method for vancomycin and teicoplanin determination in human plasma was developed in accordance with analytical quality by design (AQbD) concept and fully validated.

Materials & methods: Chromatographic separation was performed on ACQUITY UPLC C18 charge surface hybrid (CSH) column (2.1 mm × 50 mm, 1.7 μm particle size) in gradient mode and the mobile phase consisted of 0.1% formic acid in water and pure acetonitrile. The experimental design methodology was used for the definition of optimal chromatographic and protein precipitation conditions.

Results: The linearity ranges were 0.05-10 μg ml-1 for vancomycin and 0.5-200 μg ml-1 for total teicoplanin. The relative standard deviations for precision estimation were below 15% and the accuracy was within 85-115% for all quality control levels.

Conclusion: The method was utilized for glycopeptide antibiotics bioanalysis.

Keywords: AQbD; UPLC/MS/MS; glycopeptide antibiotics; plasma.

Publication types

  • Validation Study

MeSH terms

  • Anti-Bacterial Agents / blood*
  • Chromatography, High Pressure Liquid / methods*
  • Humans
  • Mass Spectrometry / methods*
  • Teicoplanin / blood*
  • Vancomycin / blood*

Substances

  • Anti-Bacterial Agents
  • Teicoplanin
  • Vancomycin