HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度  

Content Determination and Content Uniformity Test of Aminophylline and Chlorphenamine Maleate in Compound Amino-polypeptide Tablets by HPLC

作　　者：阚微娜 杨宏伟 

机构地区：[1]辽宁省药品检验检测院,沈阳110023

出　　处：《中国现代应用药学》2015年第7期835-838,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 建立HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度。方法 色谱柱为YMC Hydrosphere C18（4.6 mm×250 mm,5μm）,流动相为乙腈-0.5%磷酸溶液（用三乙胺调p H值至2.2）（10∶90）,流速为1.0 m L·min-1,柱温为30℃,检测波长为262 nm。结果 茶碱和马来酸氯苯那敏分别在0.06~0.58 mg·m L-1和2.2~20.0μg·m L-1内线性关系良好,回收率分别为100.4%和101.2%,RSD分别为0.74%和1.40%（n=9）。结论 方法快速准确,重复性好,结果可靠,可同时测定氨茶碱及马来酸氯苯那敏,为产品质量标准提高提供基础。OBJECTIVE To establish a method for the content and content uniformity of aminophylline and chlorphenamine maleate in compound amino-polypeptide tablets by HPLC. METHODS The YMC Hydrosphere C18 column（4.6 mm×250 mm, 5 μm） was used with the mobile phase of acetonitrile-0.5% H3PO4（adjust p H to 2.2 by triehtylamine）（10∶90）. The flow rate was 1.0 m L·min-1. The column temperature was 30 ℃. The wavelength was 262 nm. RESULTS The calibration curves of aminophylline and chlorphenamine maleate were 0.06-0.58 mg·m L-1 and 2.2-20.0 μg·m L-1 respectively. Their recoveries were 100.4% and 101.2%, with RSDs of 0.74% and 1.40%（n=9）, respectively. CONCLUSION The method is rapid, accurate and high efficiency to determinate aminophylline and chlorphenamine maleate simultaneously, so as to provide the basis for product quality standards.

关 键 词：复方氨肽素片 氨茶碱 茶碱 马来酸氯苯那敏 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学]