高效液相色谱法测定9-硝基喜树碱及其有关物质的含量  

Determination of 9-nitrocamptothecin and its related substances by high performance liquid chromatography

作　　者：郁颖佳[1] 高敏洁[1] 段更利[1] 

机构地区：[1]复旦大学药学院药物分析教研室,上海200032

出　　处：《中国新药与临床杂志》2006年第8期605-608,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的：建立高效液相色谱法测定9-硝基喜树碱(9-NC)及有关物质的含量。方法：采用Eclipse^(?) XDB-C18色谱柱(5μm,4．6 mm×150 mm)；以乙腈-水(28．5：71．5,V/V)为流动相；UV检测波长368 nm；流速1．0 mL·min^(-1)。结果：9-NC在0．005～0．3g·L^(-1)范围内具有良好的线性关系(r=0．99998),最低检测限0．17 ng；样品溶液在3h内稳定,日内精密度和日间精密度良好(RSD＜1．5%)；回收率为100．4%；3批样品的标示百分含量(%)分别为99．94,99．31,98．88,有关物质的百分含量分别为0．24,0．23,0．28。结论：本方法简便、灵敏,结果可靠准确,可用于9-NC及其有关物质的含量测定。AIM： To establish the high performance liquid chromatography （HPLC） for determining 9- nitrocamptothecin （9-NC） and its related substances. METHODS： The HPLC was performed on Eclipse XDB-C18 （5 μm, 4.6 mm×150 mm） column. The mobile phase consisted of acetonitrile and water （28.5 ： 71.5, V/V） . The flow rate was 1.0 mL·min^-1. The detection wavelength was set at 368 nm. RESULTS： The assay showed good linear correlation over the range of 0.005 - 0.3 g·L^-1 （r = 0.999 98） . The minimum detection limit of 9-NC was 0.17 ng. The average recovery rate of this method was 100.4 %. The sample solution was stable within 3 h. The coefficient variations of intra-and inter-day of 9-NC were less than 1.6 %. The concentrations of three samples of 9-NC were 99.94 %, 99.31%, 98.88 %, and the related substances in 9-NC were 0.24 %, 0.23 %, and 0.28 %, respectively. CONCLUSION： The HPLC is simple, sensitive, and accurate in the application to the quality control of 9-NC.

关 键 词：抗肿瘤药 喜树碱 色谱法 高压液相 有关物质 9-硝基喜树碱 

分 类 号：R927.2[医药卫生—药学] R979.1