盐酸非索非那定有关物质测定方法的建立  

Establishment of analytical method to determine related substances for fexofenadine hydrochloride

作　　者：安穗伟[1] 骆维康[1] 

机构地区：[1]广州市医药工业研究所,广州510240

出　　处：《广东药学》2005年第2期22-24,共3页Guangdong Pharmaceutical Journal

摘　　要：目的　建立盐酸非索非那定有关物质的HPLC分析方法。方法　采用苯基柱(250mm×4. 6mm, 5μ),流动相: 0. 5%磷酸二氢钠水溶液(pH4. 0) 乙腈三乙胺(60∶40∶0. 3);流速1. 5ml/min;检测波长220nm。采用归一化法测定盐酸非索非那定有关物质的含量。结论　本方法简便、快速、灵敏,可用于盐酸非索非那定有关物质的测定。Objective To establish HPLC method for determination of Fexofenadine Hyfrochloride related substances. Method The column:Hypersil Phenyl 2(5μ)(250 mm×4.6 mm).The mobile phase:0.5% monobasic sodium phosphate in water(pH 4.0)-acetonitrile(60 ∶ 40),Add 2 ml of triethylamine per liter, and mix. The flow rate:1.5 mL/min. The detection wavelength:220 nm. Calculate the content of Fexofenadine Hyfrochloride related substances with the normalization. Conclusion The method is accurate, simple, and quick. It can be used on the analysis of Fexofenadine Hyfrochloride related substances.

关 键 词：HPLC 盐酸非索非那定 有关物质 

分 类 号：R284[医药卫生—中药学]