摘要
建立HPLC法测定左乙拉西坦含量及其有关物质。选用Agilent-Zorbax SIL柱(5μm,4.6 mm×250 mm);流动相为V(乙腈)∶V(1.96 g/L硫酸水)=97.5∶2.5;流速1.0 mL/min;检测波长205 nm;柱温45℃。左乙拉西坦在40.00～240.00μg/mL浓度内线性关系良好,杂质A检测限为0.04 ng,杂质B检测限为0.096 ng,回收率99.5%～101.3%,RSD0.16%～0.57%。本试验建立的左乙拉西坦含量及其有关物质测定方法专属性强、准确度高,具有较高的灵敏度,可用于其质量控制。
An HPLC method for the determination of the content and the related substances of levetiracetam was established.An Agilent-Zorbax SIL column（5 μm,4.6 mm× 250 mm） for levetiracetam determination was used with the mobile phase of acetonitrile 1.96 g/L solution of sulfuric acid（97.5∶2.5 V/V）.The flow rate was 1.0 mL/min.The detection wavelength was 205 nm,and the colunm temperature was at 45 ℃.The calibration curve of levetiracetam content was linear in the concentration range of 40.00～240.00 μg/mL.The LOQ of impurity A was 0.04 ng,the LOD of impurity B was 0.096 ng,and the average recoveries were 99.5%～101.3% with RSDs of 0.16%～0.57%.The method is specific,accurate,high sensitivity,and can be used for quality control of levetiracetam drug substance.
出处
《化学试剂》
CAS
CSCD
北大核心
2013年第4期337-340,368,共5页
Chemical Reagents
