摘要
建立阿糖胞苷注射液中有关物质的含量测定方法。采用高效液相色谱法，色谱柱为十八烷基硅烷键合硅胶柱，流动相为磷酸盐缓冲液，体积流量1．0ml／min，检测波长为260nm，外标法计算。阿糖胞苷注射液中有关物质尿嘧啶阿拉伯糖苷及阿糖胞苷在10nin内洗脱并完全分离。尿嘧啶阿拉伯糖苷在30．64～183．84ng间线性关系良好，r=1．0000，进样量为2．45ng时仍能检出。回收率为98．4％（RSD1．2％n=5）；方法回收率、精密度良好。采用自身对照法测定除尿嘧啶阿拉伯糖苷外的其他有关物质均未超过0．5％。本法分离效果好，快速、简便，结果可靠，适用于该制剂有关物质的含量测定。
To establish a HPLC method for determination of related substances. C18 column was used. The mobile phase was composed of PBS, at a flow rate of 1.0 ml/min. The detection wavelength was 260 nm. The linear response range of uracil arabinofuranoside was 30. 64-183.84 ng（r=1. 000 0,n= 6）. The minimum limit of the detection was 2.45 ng. The mean recoveries of uracil arabinoside were 98.4%（RSD 1.2% n=5）. Any other related substances are not more than 0.5%. The method is simple and quick with good result of determination, so it is suitable for the determination of related substances in cytarabine injection.
出处
《药物生物技术》
CAS
CSCD
2009年第5期460-462,共3页
Pharmaceutical Biotechnology
