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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 a method for the detection and analysis of polysorbate 80 (aka Tween 80). Methods: Commercially available polysorbate 80 was investigated using Shimadzu's AMIX Performance matrix-assisted laser desorption / emission-time-of-flight mass spectrometry (MALDI-TOF / MS) and size exclusion chromatography. The parameters were positive ionization spectroscopy, reflection mode, an accelerating voltage of 20.0 kV, a nitrogen laser, a mass valve of m / z 500 and a matrix of cinnamic acid (CHCA). Results: Polysorbate 80 was found to be a complex mixture of polyethylene glycol, polyethylene glycol ester, isosorbide mononitrate polyethoxylate, sorbitan polyethoxylate, monoester of polysorbate / Diesters, sorbitol polyethoxylate esters and the like. The low molecular weight and high molecular weight fractions of polysorbate 80 were successfully separated by size exclusion chromatography and confirmed by MALDI-TOF / MS. Conclusion: The method is simple, accurate and can be applied to the quality control of polysorbate 80 in the future.