3-酰胺基-吲哚类衍生物及其有关物质含量测定

Determination of Contents 3-amide-indole Derivative and Related Substances

目的建立反相高效液相色谱法测定3-酰胺基-吲哚类衍生物及其有关物质含量。方法采用Diamonsil C18（250mm×4．6mm，5μm）色谱柱，流动相为甲醇：乙腈：水（43：12：45），流速1．0mL·min^-1；检测波长224nm；进样量20μL；柱温：室温。结果3-酰胺基一吲哚类衍生物与有关物质能达到较好分离，在0．04—0．16mg·mL。浓度范围内与峰面积线性关系良好，r=0．0997；方法重复性RSD为0．52％；检测限为2．65ng。结论该方法准确可靠，灵敏度高，专属性好，可用于3-酰胺基-吲哚类衍生物及其有关物质含量测定。

Objective To establish a RP-HPLC method for the determination of 3-amide-indole derivative and its related substances. Methods Diamonsil C18（250 mm×4.6mm,5μm） column was adopted. The mobile phase consisted of a mixture of methano1-acetonitrile-water（43 12 ： 45 ） at the flow rate of 1. 0 mL · min^-1. The wavelength for ultraviolet detection was 224 nm. The injection volume was 20 μL and the column temperature was room temperature. Results 3-amide-indole derivative and related substances could be well separated. The linearity of the 3-amide-indole derivative curve was well correlated （r=0.999 7） within the range of 0.04-0.16 mg· mL^-1. The RSD was 0.52% with good repeatability. The detection limit was 2.65 ng. Conclusion The method is accurate, reliable, sensitive and specific, which can be used for the determination of 3- amide-indolederivative and related substances.