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

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.