ABSTRACT
OBJECTIVE: To establish a method for the separation and identification of the components in polysorbate 80 and to lay the foundation for identifing the sensitinogen of polysorbate 80. METHODS: Polysorbate 80 samples from both domestic and foreign manufacturers were collected. The separation condition was first established using HPLC-ELSD, and then the chemical composition of each chromatographic peak was identified by HPLC-MS. RESULTS: The chemical components with different types of structures were efficiently separated, and each chromatographic peak was properly assigned. Polysorbate 80 samples of different batches and manufacturers showed different chemical compositions and relative contents. There was illegal blending during the production of polysorbate 80. CONCLUSION: The proposed method is rapid and simple, which is not only suitable for the process control of polysorbate 80 but also lays foundation for further investigation of the physical and chemical properties of the components thus to find the sensitinogen. Copyright 2012 by the Chinese Pharmaceutical Association.