摘要
目的采用HPLC法测定左乙拉西坦中的有关物质。方法采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),流动相为0.01 mol.L-1磷酸氢二钠-乙腈-三乙胺(92∶8∶0.1,磷酸调pH6),流速1.0 mL.min-1,检测波长205 nm。结果吡咯酮酸杂质相对于主成分左乙拉西坦的tR约为0.51,校正因子为1.15,检测限为2 ng,4批样品中吡咯酮酸的含量为0.027%～0.029%,其他有关物质为0.019%～0.108%。结论所建方法准确、简便、快速,适用于左乙拉西坦中微量杂质的控制。
OBJECTIVE To establish an RP-HPLC method for determination of the related substances in Levetiracetam.METHODS The analytical column was Diamonsil C18 column（250 mm×4.6 mm,5 μm）.The mobile phase consisted of phosphate buffer（0.01 mol·L-1 NaH2PO4）-acetonitrile-triethylamine（92：8：0.1,adjusting pH to 6 with phosphoric acid）.The flow rate was 1.0 mL·min-1 and the detective wavelength was 205 nm.RESULTS The relative retention time between（S）-α-Ethyl-2-oxo-1-pyrrolidineacetic and Levetiracetam was about 0.51 with the correction factor of 1.15,the detection limit of Levetiracetam was 2 ng.in four batches of samples,the contents of（S）-α-ethyl-2-oxo-1-pyrrolidineacetic and related substances were 0.027%-0.029% and 0.019%-0.108%,respectively.CONCLUSION The method is accurate,simple,sensitive and suitable for quality control of trace impurities in Levetiracetam.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2011年第4期382-383,共2页
West China Journal of Pharmaceutical Sciences
