Analysis of the Chemical Composition of Polysorbate 80

Chinese Pharmaceutical Journal ›› 2012, Vol. 47 ›› Issue (2) : 149-154.

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PDF(1883 KB)
Chinese Pharmaceutical Journal ›› 2012, Vol. 47 ›› Issue (2) : 149-154.

Analysis of the Chemical Composition of Polysorbate 80

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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.

Key words

polysorbate 80 / chemical composition / evaporative light-scattering detector / MS detector

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Analysis of the Chemical Composition of Polysorbate 80[J]. Chinese Pharmaceutical Journal, 2012, 47(2): 149-154

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