中文摘要：

目的建立高效液相色谱法测定2-吲哚酮类衍生物含量及其有关物质的方法。方法采用Agilent Eclipse XDB-C18色谱柱（250 mm×4.6 mm,5μm）;流动相为乙腈-水,梯度洗脱;流速1.0 mL·min^-1;柱温35℃;进样量20μL;检测波长257 nm。结果该方法系统适应性良好,在40-300μg·mL^-1浓度范围内线性关系良好（r=0.9994）,仪器精密度良好（RSD〈1%）,检测限为8 ng。结论该方法准确、简便、灵敏、专属性好,可用于2-吲哚酮类衍生物及其有关物质质量控制。

英文摘要：

Objective To establish an high performance liquid chromatography method for determination of 2-indole ketone derivative and its related substances. Methods Agilent Eclipse XDB-C18（ 250 mm × 4. 6 mm,5 μm） column was adopted.The mobile phase was acetonitrile-water with gradient elution mode at a flow rate of 1. 0 m L · min-1; the column temperature was 35 ℃; the injection volume was 20 μL and the detection wavelength was set at 257 nm. Results 2-indole ketone derivative ID and related substances could be well separated. The 2-indole ketone derivative had good linear correlation（ r= 0.999 4） within the range of 40-300 μg·m L^-1. It had a good precision（ RSD 〈1%）. The limit of detection was 8 ng.Conclusion The method is accurate,simple,sensitive and selective,which can be used for the quality control of 2-indole ketone derivative and related substances.