离子色谱-电导法测定盐酸布替萘芬中四丁基溴化铵的残留  

Determination of Tetrabutylammonium Bromide Residues in Butenafine Hydrochloride by Ion Chromatography-conductivity

作　　者：王东旭 曲喜龙 刘发贵 张丽 李铁健 张贵民 WANG Dong-xu;QU Xi-long;LIU Fa-gui;ZHANG Li;LI Tie-jian;ZHANG Gui-Min(Shandong New Times Pharmaceutical Co.,Ltd.,Linyi 273400,China;Lunan Pharmaceutical Group Co.,Ltd.,Linyi 276002,China)

机构地区：[1]山东新时代药业有限公司,山东临沂273400 [2]鲁南制药集团股份有限公司,山东临沂276002

出　　处：《海峡药学》2022年第4期104-107,共4页Strait Pharmaceutical Journal

摘　　要：目的建立一种方法检测水不溶性原料药盐酸布替萘芬中四丁基溴化铵残留。方法采用阳离子交换色谱法配合电导检测器,选择Dionex IonPac^(TM) CS17色谱柱,Dionex CSRS^(TM) 300抑制器,以二氯甲烷和水对原料药中四丁基溴化铵进行萃取处理。结果在0.012 mg·mL^(-1)~0.080 mg·mL^(-1)范围内,四丁基溴化铵质量浓度与峰面积呈良好的线性关系,定量限为0.012 mg·mL^(-1),检测限为0.006 mg·mL^(-1),测试溶液回收率为92.09%~113.96%。结论方法可用于盐酸布替萘芬中残留四丁基溴化铵的检测。OBJECTIVE To establish a method for the determination of tetrabutylammonium bromide residues in butenafine hydrochloride,a water-insoluble raw material drug.METHODS We chose the method of cation exchange chromatography combined with conductivity detector.Dionex IonPacTM CS17 column and Dionex CSRSTM 300 suppressor were selected to extract tetrabutylammonium bromide from raw drug with dichloromethane and water.RESULTS In the range of 0.012-0.080 mg·mL^(-1),there was a good linear relationship between the mass concentration of tetrabutylammonium bromide and the peak area,the quantitative limit was 0.012 mg·mL^(-1),the detection limit was 0.006 mg·mL^(-1),and the recovery rate of the test solution was 92.09%-113.96%.CONCLUSION The method can be used for the determination of residual tetrabutylammonium bromide in Butenafine hydrochloride.

关 键 词：离子色谱法 盐酸布替萘芬 四丁基溴化铵 电导检测器 

分 类 号：R927[医药卫生—药学]