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5~160 μg·mL-1浓度范围内线性关系良好,最低检测限1.3 μg·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 capillary zone electrophoresis(CZE) method for the determination of darusentan.Methods:An uncoated fused silica capillary column was used,with running buffer of 30 mmol·L-1 disodium hydrogen phosphate-phosphate buffer (pH 7.05),at the applied voltage of 20 kV and the detection wavelength of 214 nm.Results:Darusentan and the degradations treated with high humidity,over heating,acid,alkali,intense light,oxidation could be separated well by the developed method.The calibration curve for darusentan was linear in the concentration range of 5-160 μg·mL-1 with the detection limit of 1.3 μg·mL-1.Conclusion:The method is simple,sensitive,specificity,accurate and successfully applied to the determination of darusentan.It can be used for quality control of darusentan in production process.