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∗

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。%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 mL•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•mL-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.