Abstract:
As key solubilising excipients in injections, nonionic surfactants such as polysorbate 80 are an important source of risk for triggering adverse reactions in preparations, and the establishment of the accurate analysis method system for them has become a key link in the quality control of injections. In order to effectively control and monitor nonionic surfactants in injections, the chromatographic analysis methods, including reversed-phase liquid chromatography, high performance liquid chromatography-mass spectrometry, gel chromatography, mixed-mode chromatography and two-dimensional liquid chromatography, were reviewed, aiming to provide references for the control and monitoring of nonionic surfactants in the biomedical field (58 ref. cited).