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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。
Objective: To establish a method for simultaneous determination of the main drug and related substances in caffeic acid tablets. Methods: Using high performance liquid chromatography. The column was Diamosil C18, the mobile phase was methanol-0.15% sodium dihydrogen phosphate buffer, and the pH value was adjusted to 4.0 with phosphoric acid (pH = 4.0) = 23:77, the flow rate was 1.0 mL · min-1 and the detection wavelength was 323 nm. Results: The linear range of caffeic acid was 5.038-100.76 μg · mL-1 (r = 0.999 7). The average recovery was 99.04%, RSD was 0.17% (n = 9) The resolution was good, with the limits of detection of 16.7 and 85.3 ng · mL-1, respectively. Conclusion: This method is simple, accurate, specific, and high sensitivity, which can effectively control the quality of caffeic acid tablets.