反相高效液相色谱法测定沙利度胺的有关物质  

Determination of Related Substances in Thanlidomide and in Its Tablets by HPLC Gradient Elution

作　　者：欧贝丽[1] 尹小英[1] 徐菊芳[1] 胡育筑[1] 

机构地区：[1]中国药科大学分析化学教研室,南京210009

出　　处：《中国药学杂志》2008年第6期465-468,共4页Chinese Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法测定沙利度胺原料药及片剂中有关物质含量的方法。方法采用C_(18)色谱柱,以乙腈-水-磷酸(17:83:0.1)为流动相A,以乙腈-水-磷酸(27:73:0.1)为流动相B,梯度洗脱,柱温为25℃;检测波长218 nm;流速1.0 mL·min^(-1)。结果主成分与有关物质及各降解成分完全分离,单个杂质和总杂质量均低于限量要求。结论该方法专属性强、灵敏度高、结果准确,适合沙利度胺及其片剂中的有关物质的测定。OBJECTIVE To establish an HPI,C method for determination of related substances of thanlidomide and its tablets. METHODS The RP-HPLC method was used. The separation was perfnm3ed on Kromasil-column of C18 by gradient elution with mobile phases of A [ CH3 C N-H2O-H3 PO4 （ 17 ： 83 ： 0. 1 ） ] and B [ CH3 CN-H2o-H3 PO4 （ 27： 73： 0. 1 ） ] ; the column was maintainded at 25℃ ; the flow rate was 1 mL ·min^-1 and the detection wavelength was set at 218 nm. RESULTS Related substances and degraded substances were completely separated from main constituent; single and total impurities were below the limits, CONCLUSION The method was selective, accurate, sensitive and it is suitable for determination of related substances in thanlidomide and its tablets,

关 键 词：高效液相色谱法 梯度洗脱 沙利度胺 有关物质 

分 类 号：R917[医药卫生—药物分析学]