HPLC法同时测定复方二氯醋酸二异丙胺注射液两组分的含量  

Simultaneous Determination of Two Components in Compound Diisopropylamine Dichloroacetate Injection by HPLC

作　　者：陈航[1] 纪宇[1] 邓丽明[2] 

机构地区：[1]江苏省药品检验所,南京210008 [2]广东药学院,广州510006

出　　处：《中国药品标准》2007年第5期42-45,共4页Drug Standards of China

摘　　要：目的：建立同时测定复方二氯醋酸二异丙胺注射液中二氯醋酸二异丙胺和葡萄糖酸钠含量的高效液相色谱法。方法：采用CN柱（250×4.6mm,5μm）;以0.9%NaCl溶液为流动相;流速：0.8mL/min;检测波长：220nm;进样量：20μl;柱温：35℃。结果：线性范围：二氯醋酸二异丙胺为482-1125μg/ml,r=0.9999;葡萄糖酸钠为458-1068μg/ml,r=0.9998;两者的平均回收率分别为100.7%与99.4%,RSD分别为0.19%与0.2%。结论：本方法简便,快速,准确,适用于复方二氯醋酸二异丙胺注射液的含量测定。Objective：An HPLC method for simultaneous determination of Diisopropylamine Dichloroacetate and Sodium Gluconate in Compound Diisopropylamine Dichloroacetate Injection was developed. Method： A CN column（250 × 4. 6mm, 5μm） was selected. The mobile phase was 0. 9 % NaCl. The flow rate was 0.8 ml/min,and the detection wavelength was 220nm. The injection volume was 20μl and the column temperature was 35℃. Results：Both Diisopropylamine Dichloroacetate and Sodium Gluconate showed good linearity（r=0. 9999 and 0.9998）in the range of 482-1125μg/ml and 458-1068μg/ml with average recoveries 100.7%±0.2% and 99.4±0. 2 % （n=9） respectively. Conclusions ： The method is simple, rapid and accurate, which can be used for the determination of Compound Diisopropylamine Dichloroacetate Injection.

关 键 词：二氯醋酸二异丙胺 葡萄糖酸钠 高效液相色谱法 含量测定 

分 类 号：R589.2[医药卫生—内分泌] R284.1[医药卫生—内科学]