亲水作用色谱法测定阿卡波糖含量

发布时间：2019-01-14 16:57

【摘要】：目的:建立采用亲水作用色谱(HILIC)测定阿卡波糖含量的新方法。方法:采用亚乙基桥杂化酰胺色谱柱(XBridge Amide,4.6 mm×250 mm,3.5μm),通过正交设计试验考察了流动相pH、盐浓度、柱温及流速等色谱参数的影响,最终确立色谱条件:以10 mmol·L~(-1)乙酸铵缓冲盐水溶液(pH 9.0)-乙腈(25∶75)为流动相,流速1.2 mL·min~(-1),柱温65℃,检测波长210 nm。结果:阿卡波糖与杂质A可完全分离,且阿卡波糖质量浓度在0.2~1.2 mg·mL~(-1)范围内线性关系良好(r=0.999 8);平均回收率为99.5%;供试品溶液在24 h内稳定;检测限(S/N=3)为0.08μg;3批胶囊样品中阿卡波糖含量分别为98.6%、100.0%、98.5%。结论:本法可用于阿卡波糖的质量控制。
[Abstract]:Objective: to establish a new method for the determination of acarbose by hydrophilic interaction chromatography (HILIC). Methods: XBridge Amide,4.6 mm 脳 250 mm,3.5 渭 m), column was used to study the effects of the chromatographic parameters such as the concentration of pH, salt, the column temperature and the flow rate of the mobile phase by orthogonal design. The chromatographic conditions were as follows: 10 mmol L ~ (-1) ammonium acetate buffer salt solution (pH 9.0) -acetonitrile (25:75) as mobile phase, flow rate 1.2 mL min~ (-1), column temperature 65 鈩，

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