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期刊名称：药物分析杂志
主管单位：中国科学技术协会
主办单位：中国药学会承办：中国食品药品检定研究院
主编：金少鸿
地址：北京天坛西里2号
邮政编码：100050
电话：010-67012819,67058427 电子邮箱：ywfx@nifdc.org.cn
国际标准刊号：ISSN 0254-1793
国内统一刊号：CN 11-2224/R
邮发代号：2-237
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毛细管区带电泳法测定达卢生坦的含量___
Determination of darusentan by capillary zone electrophoresis
分类号：
出版年·卷·期（页码）：2010,30 (4):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
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.
-----英文摘要：---------------------------------------------------------------------------------------
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.
-----参考文献：---------------------------------------------------------------------------------------
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2Sarafidis PA,Bakris G.Resistant hypertension-An overview of evaluation and treatment.J Am Coll Cardiol,2008,52(22):1749
3Epstein BJ.Efficacy and safety of darusentan:a novel endothelin receptor antagonist.Ann Pharmacother.2008,42 (7):1060
4Petersen B,Deja M,Bartholdy R,et al.Inhalation of the ETA receptor antagonist LU-135252 selectively attenuates hypoxic pulmonary vasoconstriction.Am J Physiol Regul Integr Comp Physiol.2008,294 (2):R601
5L scher TF,Enseleit F,Pacher R,et al.Hemodynamic and neurohumoral effects of selective endothelin A (ETA) receptor blockade in chronic heart failure.Circulation,2002,106 (19):266
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