Preparation and purity determination of the reference standards for chemical compositions of polysorbate 80 / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a new method for the preparation and purity determination of the reference standards for eight types of chemical compositions in polysorbate 80. METHODS: Polyoxyethylene 24 sorbitan oleate and polyoxyethylene 12 isosorbide oleate were synthesized respectively. Medium and low pressure preparative chromatography and flash column were used to separate and purify the constituents, and their structures were elucidated by IR, Raman, MS, 1H-NMR and 13C-NMR. RESULTS: Eight single chemical compositions of polysorbate 80 were obtained, the purities of which were greater than 99.5% tested by HPLC, meeting the requirement as a reference standard. CONCLUSION: A directed synthesis together with a medium and low pressure preparative chromatography method is established for the first time which can accurately and rapidly prepare the reference standards for eight chemical compositions of polysorbate 80. And for the first time the spectral data of the eight chemical components were reported.