ABSTRACT
OBJECTIVE: To point out the problems of the SEC-ELSD method for determination of polysorbate 80 in traditional Chinese medicine injections, and discuss the method. METHODS: The retention behaviors of eight types of chemical compositions in polysorbate 80 in size exclusion chromatography were studied according to the chromatographic conditions of SEC-ELSD method. RESULTS: Not all of the chemical compositions had same chromatographic retention time, some of them showed no chromatographic peaks in the chromatographic conditions of SEC-ELSD method. CONCLUSION: In order to ensure the rational use of SEC-ELSD method, researchers must be concerned about the state of the surfactant molecules in the mobile phase and the interaction between surfactant molecules with the stationary phase. A new standard of polysorbate 80 must be implemented, the core of which is controlling the chemical compositions.