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目的:建立测定达卢生坦含量的高效毛细管区带电泳法。方法:采用未涂层融硅石英毛细管;以30 mmol·L~(-1)磷酸氢二钠-磷酸(pH 7.05)为运行缓冲液;工作电压20 kV;检测波长214 nm。结果:在上述色谱条件下,经高湿、高热、酸、碱、光照、氧化破坏所产生的相关杂质彼此之间与达卢生坦主峰可得到有效的分离;达卢生坦在5～160μg·mL~(-1)浓度范围内线性关系良好,最低检测限1.3μg·mL~(-1)。结论:采用毛细管电泳法分析达卢生坦的含量,方法简便、灵敏、专属性强,准确度好。可用于达卢生坦的质量控制与生产过程中有关物质的检查。
Objective: To establish a high performance capillary zone electrophoresis method for the determination of daltesentine. Methods: Uncoated fused silica capillaries were used. 30 mmol·L -1 disodium hydrogen phosphate-phosphate (pH 7.05) was used as running buffer. The working voltage was 20 kV and the detection wavelength was 214 nm. Results: Under the above chromatographic conditions, related impurities produced by high humidity, high heat, acid, alkali, light and oxidative damage can be effectively separated from dalouxantan main peak. Daluosheng is in the range of 5 ~ 160μg · ML ~ (-1) concentration range of good linearity, the minimum detection limit of 1.3μg · mL ~ (-1). Conclusion: The content of Darulitan is determined by capillary electrophoresis. The method is simple, sensitive, specific and accurate. It can be used for the quality control of dalofostane and the inspection of related substances in the production process.