聚山黎酯80的MALDI-TOF/MS和色谱分析(英文)

MALDI- TOF / MS and chromatographic analysis of polysorbate 80

目的:建立聚山梨酯80(又名吐温80)的检测分析方法。方法:使用岛津公司的AMIX Performance基体辅助激光解吸飞行时间质谱(MALDI-TOF/MS)和分子排阻色谱对市售的聚山梨酯80进行研究。参数为正离子电离光谱,反射模式,加速电压20.0 kV,氮激光,质量阀为m/z 500,基质为肉桂酸(CHCA)。结果:发现聚山梨酯80为复杂的混合物,包括聚乙二醇、聚乙二醇酯、单硝酸异山梨聚乙氧基化物、脱水山梨糖醇聚乙氧基化物、聚山梨酯的单酯/二酯、山梨糖醇聚乙氧基化物酯等。分子排阻色谱方法成功分离聚山梨酯80的低分子量和高分子量成分,并用MALDI-TOF/MS证明。结论:本方法操作简便,结果准确,未来可以用于聚山梨酯80的质量控制。

Objective： To establish the analysis method for polysorbate 80（polysorbate 80）. Methods： The MALDI-TOF/MS spectroscope and the size exclusion chromatography（SEC）were used for analysis of commercial polysorbate 80.The parameters were positive ionization spectra,reflection mode,20.0 kV acceleration voltage,nitrogen laser,quality valve at m/z 500.Thematrix was a-cyano-4-hydroxycinnamic acid（CHCA）. Results： The results revealed a complex mixture of oligomers that included polyethylene glycols,polyethylene glycol esters,isosorbidepolyethoxylates,sorbitanpolyethoxylates,polysorbate monoesters/diesters,and sorbitol polyethoxylate esters.The size exclusion chromatography successfully separated the low and high molecular mass constituents of polysorbate 80,which was proved by MALDI-TOF/MS. Conclusion： The method is simple,accurate,and can be used in quality control of polysorbate 80.