Research progress on quality evaluation and assay methods of polysorbate 80 / 药物评价研究

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.