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气相色谱法测定复方乳酸钠山梨醇注射液中的山梨醇含量
引用本文:马忠心,于玥,施岩,时文奇. 气相色谱法测定复方乳酸钠山梨醇注射液中的山梨醇含量[J]. 天津药学, 2010, 22(4): 9-11
作者姓名:马忠心  于玥  施岩  时文奇
作者单位:中国大冢制药有限公司,天津,300382
摘    要:目的:建立山梨醇的毛细管气相色谱分析方法。方法:山梨醇经乙酸酐衍生化为沸点较低的山梨醇六乙酯,用HP-5毛细管色谱柱分离,火焰离子化检测器(FID)进行检测。色谱柱温度为220℃、进样口和检测器的温度均为290℃,氮气流速3 ml/min。结果:优化了样品衍生化和色谱分析条件,实现了杂质与山梨醇的分离,排除了杂质对山梨醇测定的干扰。本方法的线性范围为0~60 mg/ml,检出限为0.01 mg/ml,日内精密度RSD为0.081%,日间精密度RSD为0.749%~0.872%,平均回收率为99.8%~100.0%,RSD为0.049%。结论:本方法操作简单、灵敏、可靠,能满足山梨醇定量分析的要求。

关 键 词:山梨醇  毛细管气相色谱  含量测定

Determination of D -sorbitol in compound sodium lactate and sorbitol injection by capillary gas chromatography
Ma Zhongxin,Yu Yue,Shi Yan,Shi Wenqi. Determination of D -sorbitol in compound sodium lactate and sorbitol injection by capillary gas chromatography[J]. Tianjin Pharmacy, 2010, 22(4): 9-11
Authors:Ma Zhongxin  Yu Yue  Shi Yan  Shi Wenqi
Affiliation:(China otsuka Pharmaceutical Co Ltd,Tianjin 300382)
Abstract:Objective: To develop a capillary gas chromatographic method for the determination of D-sorbitol.Methods: The derivative of sorbitol,sorbital hexacetatate,the boiling point of which is lower than that of its origin,was separated by an HP-5 capillary chromatographic column at 220 ℃ and determined with an ionization detector(FID).The temperature of the detector and the inlet of samples was 290 ℃,and the nitrogen flow rate was of 3 ml/min.Results: The conditions for both the derivatization of sorbitol and the chromatographic separation were optimized and sorbitol was completely separated from impurities.The linear range was 0~60 mg/ml and the limit of detection of was 0.01 mg/ml.The precisions of within-day and between-days were 0.081% and 0.749% ~0.872% respectively.The average recovery was 99.8%~100.0% and average RSD was 0.049%.Conclusions: The method developed in the present study is simple,sensitive and reliable for quantitative analysis of sorbitol.
Keywords:D-sorbitol  capillary gas chromatography  determination
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