气相色谱法同时测定木糖醇氯化钠注射液中4种多元醇的含量

GC simultaneous determination of four components in xylitol and sodium chloride injection

目的:建立测定木糖醇氯化钠注射液中4种多元醇(L-阿拉伯糖醇,甘露醇,半乳糖醇,山梨醇)的气相色谱(GC)法。方法:以赤藻糖醇为内标,采用毛细管气相色谱法对木糖醇氯化钠注射液中4种多元醇进行含量测定。结果:L-阿拉伯糖醇,甘露醇,半乳糖醇和山梨醇在各自的浓度范围内均具有良好的线性关系(r均为0.999以上);平均回收率(n=9)分别为98.9%～100.5%,101.0%～101.6%,99.0%～102.1%和100.9%～102.4%。结论:本方法简单、结果准确、重现性好,可更好的控制药品质量。

Objective：To develop a GC method for simultaneous determination of L-arabinitol,galactitol,mannitol and sorbitol in xylitol and sodium chloride injection.Methods：GC method was applied for determination of four components and using erythritol as the internal standard.Results：There was a good linear relationship in the concentration range measured for L-arabinitol,galactitol,mannitol and sorbitol;The average recoveries（n=9） of L-arabinitol,galactitol,mannitol and sorbitol were 98.9%-100.5%,101.0%-101.6%,99.0%-102.1%和100.9%-102.4%,respectively.Conclusion：The method was simple,accurate and reproducible.It was better for quality control of xylitol and sodium chloride injection.