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机构地区:[1]复旦大学药学院药物分析教研室,上海200032
出 处:《药物分析杂志》2007年第6期838-840,共3页Chinese Journal of Pharmaceutical Analysis
摘 要:目的:研究影响因素试验(光线、温度、湿度)、加速试验、长期试验中9-硝基喜树碱(9-NC)的外观性状、有关物质(12-NC)及含量的变化,初步考察其稳定性。方法:利用高效液相色谱法,通过与对照品比较,观察变化的情况。色谱柱:Eclipse^XDB-C_(18)(4.6 mm×150 mm,5μm);流动相:乙腈-水(28.5:71.5);流速:1.0 mL·min^(-1);检测波长:368 nm;柱温:25℃。结果:9-NC 仅对光不稳定,其外观性状、有关物质及含量在高温、高湿度试验,加速试验和长期试验中无明显变化。结论:9-NC 应当避光保存,保证其相对稳定。Objective: To study stability of 9 - nitrocamptothecin (9 - NC) under the influence of stress testing, accelerated testing and long - term testing. Method: By observing change of 9 - NC compared with control sample by HPLC. 9 - NC and its related substances were separated and determined on Eclipse XDB - C18 (4. 6 mm × 150 mm,5 μm)column with mobile phase of acetonitrile- water(28.5: 71.5)and a flow rate of 1.0 mL · min^-1 at 25 ℃ with the UV detection at 368 nm. Results:9 -NC was easy to change due to light and was relatively stable due to temperature, humidity, accelerated testing and long - term testing. Conclusion: 9 - NC should be stored away from light to keep its stable.
关 键 词:9-硝基喜树碱(9-NC) 高效液相色谱 稳定性
分 类 号:R917[医药卫生—药物分析学]
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