茴拉西坦胶囊的有关物质测定  

Determination of Related Substances in Aniracetam Capsules

作　　者：李玮玲[1] 

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《今日药学》2014年第6期421-423,共3页Pharmacy Today

摘　　要：目的建立RP-HPLC法测定茴拉西坦胶囊的有关物质。方法以乙腈-0.1%冰醋酸溶液（30∶70）为流动相,Techmate C18色谱柱（250 mm×4.6 mm,5μm）,流速为1 mL/min,检测波长254 nm。结果采用主成分自身对照的方法测定,方法的专属性强,茴拉西坦在0.441 56~22.078μg/mL范围内呈线性,线性方程为A=32.050 1C＋0.991 8,相关系数为：r=0.999 9（n=5）。最低检测限为0.084ng。结论方法可用于茴拉西坦胶囊有关物质的测定。Objective To establish HPLC method for the determination of related substances in Aniracetam capsules.Methods The test used a Techmate C18column. The mobile phase consisted of acetonitrile： 0. 1% acetic acid solution（ 30∶70,v /v）. The flow rate was 1 mL /min,detection wavelength at 254 nm. Results Main component self-compare can be used when testing related substances. The method was sensitiveness and specificity. Aniracetam had a good linear relation in the range of 0. 441 56 ~ 20. 078 μg /mL,the calibration curve was A = 32. 050 1C＋0. 991 8,r = 0. 999 9（ n = 5） and the limit of detection was 0. 084 ng. Conclusion The method is simple,sensitive and rapid,and it can be used for the determination of related substances in Aniracetam capsules.

关 键 词：HPLC 茴拉西坦胶囊 有关物质 主成分自身对照 

分 类 号：R284[医药卫生—中药学]