Sensitive Method for Endotoxin Determination in Nanomedicinal Product Samples

Abstract

<b>Aim:</b> 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. <b>Materials & methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> The method is sensitive, straightforward and accurate in determining and quantifying endotoxin in nanomedicinal product samples.