Sensitive method for endotoxin determination in nanomedicinal product samples

Christina Giannakou*, Kukka Aimonen, Louis van Bloois, Julia Catalan, Robert E. Geertsma, Eric R. Gremmer, Wim H. de Jong, Peter H. J. Keizers, Paul L. W. J. Schwillens, Rob J. Vandebriel, Margriet V. D. Z. Park

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

10 Citations (Web of Science)

Abstract

Aim: Nanomaterials and nanomedicinal products tend to interfere with various commonly used assays, including regulatory required endotoxin detection methods for medicines. We developed a method to quantify endotoxin levels that is compatible with nanomaterials and nanomedicinal products. Materials & methods: The method is based on measuring endotoxin indirectly via 3-hydroxylated fatty acids of lipid-A, using Ultra High Performance Liquid Chromatography coupled with mass spectrometry. The outcome was related to results of the commonly used Limulus Amebocyte Lysate method. Results: The ultra high performance liquid chromatography coupled with mass spectrometry method has clear advantages compared with other endotoxin determination assays; particularly the absence of nanospecific interference. Conclusion: The method is sensitive, straightforward and accurate in determining and quantifying endotoxin in nanomedicinal product samples.

Original languageEnglish
Pages (from-to)1231-1246
Number of pages16
JournalNanomedicine
Volume14
Issue number10
DOIs
Publication statusPublished - May 2019

Keywords

  • fatty acids
  • interference
  • LAL assay
  • lipopolysaccharide
  • nanomaterials
  • nanomedicine
  • GAS-CHROMATOGRAPHY
  • BACTERIAL LIPOPOLYSACCHARIDES
  • MASS-SPECTROMETRY
  • NANOPARTICLES
  • NANOMATERIALS
  • CONTAMINATION
  • DOXORUBICIN
  • TOXICITY
  • DELIVERY
  • SYSTEMS

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