Research progress on quality evaluation and assay methods of polysorbate 80
10.7501/j.issn.1674-6376.2017.07.026
- VernacularTitle:聚山梨酯80质量评价及检测方法的研究概况
- Author:
xing Li NIE
1
;
qing Yu HE
;
Zhong DAI
;
dong Jian YU
;
cheng Shuang MA
Author Information
1. 中国食品药品检定研究院
- Keywords:
polysorbate 80;
quality standard;
chemical composition determination;
impurity test;
assay
- From:Drug Evaluation Research
2017;40(7):1005-1012
- CountryChina
- Language:Chinese
-
Abstract:
Research progress ofpolysorbate 80 was summarized,including standards,chemical composition and impurity test.Assay methods of polysorbate 80 in preparations were also summarized.In addition,characteristics of the current technologies were discussed.Compositions of polysorbate 80 could be detected directly by spectrophotometry,SEC-ELSD or LC-MS methods.In addition,they could be analyzed indirectly by determing the hydrolysates with HPLC-UV or GC methods.In recent years,remarkable progress has been achieved in chemical composition determination and impurity test ofpolysorbate 80.But assay method of the excipient in related drugs need further study,due to large difference between purities ofpolysorbate 80 raw materials.
