HPLC法同时测定咖啡酸片的主药和有关物质含量

目的:建立同时测定咖啡酸片中主药和有关物质含量的方法。方法:采用高效液相色谱法。色谱柱为Diamosil C18,流动相为甲醇-0.15%磷酸二氢钠缓冲液用磷酸调节pH值至4.0)=23∶77,流速为1.0 mL·min-1,检测波长为323 nm。结果:咖啡酸检测浓度线性范围为5.038～100.76 μg·mL-1(r=0.999 7);平均回收率为99.04%,RSD=0.17%(n=9);有关物质各杂质与主峰之间的分离度良好,检测限和定量限分别为16.7、85.3 ng·mL-1。结论:本法简便、准确、专属性好、灵敏度高,可有效控制咖啡酸片的质量。

Content Determination of Main Component and Its Related Substances in Caffeic Acid Tablets by HPLC

OBJECTIVE:To develop a method for the content determination of main component and its related substances in Caffeic acid tablets.METHODS:HPLC method was used on Diamonsil C18 column with methanol-0.15%NaH2PO4(pH adjusted to 4.0 using phosphoric acid)=23:77 as the mobile phase at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 323 nm.RESULTS:The linear range of caffeic acid was 5.038～100.76 μg·mL-1(r=0.999 7) with an average recovery of 99.04%(RSD=0.17%,n=9).Good separation of main peak,impurity and its related substances could be achieved.The limit of detection and quantification were 16.7 ng·mL-1 and 85.3 ng·mL-1.CONCLUSION:The method is simple,accurate,specific and sensitive,and it can be used for the quality control of Caffeic acid tablet.