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

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 C-18 charge surface hybrid (CSH) column (2.1 mm x 50 mm, 1.7 mu m 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 mu g ml(-1) for vancomycin and 0.5-200 mu g 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.