[关键词]
[摘要]
目的:建立注射用银杏二萜内酯中甘露醇和葡甲胺含量测定方法。方法:采用HPLC-ELSD法,以乙腈-50 mmol·mL-1 乙酸铵为流动相,色谱柱Waters XBridge Amide(4.6 mmx150 mm,3.5 μm);梯度洗脱,流速1.0 mL·min-1;柱温30℃;漂移管温度90℃,氮气流速2.0 L·min-1。结果:甘露醇在1.966 5~19.665 μg 范围内呈良好线性关系,平均回收率为100.57%(RSD=0.92%,n=9);葡甲胺在0.483 8~4.638 μg 范围内呈良好线性关系,平均回收率为100.67%(RSD=0.72%,n=9)。结论:该方法简便准确,重复性好,可作为测定注射用银杏二萜内酯中甘露醇和葡甲胺的含量测定方法。
[Key word]
[Abstract]
This study was aimed to develop the method for determination of mannitol and meglumine in diterpene lactones of Ginkgo Injection. The HPLC-ELSD was used to determine mannitol and meglumine in diterpene lactones of Ginkgo Injection. The analysis was carried out on Waters XBridge Amide (4.6 mm x150 mm, 3.5 μm) column.The mobile phase was the mixture of acetonitrile, and 50 mmol·mL-1 ammonium acetate with a linear gradient elution at a flow rate of 1.0 mL·min-1. The column temperature wad maintained at 30℃. The operating conditions of the ELSD were a nebulizer nitrogen with the flow rate of 2.0 L·min-1 and an evaporator tube at the temperature of 90℃.The results showed that mannitol had a good linear relationship in a range of 1.9665 μg - 19.665 μg. The average recovery rate was 100.57% (RSD = 0.92%, n = 9). The meglumine showed a good linear relationship in a range of 0.4838 μg - 4.638 μg. The average recovery rate was 100.67% (RSD = 0.72%, n = 9). It was concluded that this method was simple and accurate with good reproducibility. It met with the requirement of the determination of the contents of mannitol and meglumine in diterpene lactones of Ginkgo Injection.
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[基金项目]
科学技术部国家重大新药创制项目(2013ZX09402203):现代中药创新集群与数字制药技术平台,负责人:王振中。