HPLC法测定咳特灵胶囊中马来酸氯苯那敏的含量及含量均匀度  

Determination of content and content uniformity of chlorphenamine maleate in Keteling capsules by HPLC

作　　者：周娟[1] 朱玲[1] 

机构地区：[1]安徽省黄山市药品检验所,安徽黄山245000

出　　处：《安徽医药》2010年第4期406-407,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立用HPLC法测定咳特灵胶囊中马来酸氯苯那敏的含量及含量均匀度。方法采用Gemini C18(250 mm×4.6mm,5μm)色谱柱,检测波长226 nm,甲醇-庚烷磺酸钠醋酸溶液[1](取庚烷磺酸钠2.0 g,加冰醋酸10 ml,用水稀释至400 ml)(60∶40)为流动相,流速为1.0 ml.min-1。外标法测定含量。结果精密度及回收率结果良好,平均回收率为98.6%(n=5),RSD=2.0%。结论方法准确可靠,可用于咳特灵胶囊中马来酸氯苯那敏的含量及含量均匀度的测定。Aim To develop an HPLC method tor determination of content and content uniformity of chlorphenamine maleate in Keteling capsules. Methods A Gemini C 18 column （250 mm × 4.6 mm,5 μm） was adopted with a mixure of methanol and N-heptane solution of sodium acetate （ sodium heptane 2.0 g, added with glacial acetic acid 10 ml, diluted to 400 ml with water） （60：40） as mobile phase. The flow rate was 1.0 ml· min^-1 and the UV detection wavelength was set at 226 nm, and content was calculated by external standard method. Results The average recoverwas 98.6%, and RSD was 2.0%. Conclusions This method is reliable, accurate and suitable for the determination of content and content uniformity of chloqphenamine maleate in Keteling capsules.

关 键 词：HPLC 咳特灵胶囊 马来酸氯苯那敏 

分 类 号：R927.2[医药卫生—药学]