高效液相色谱法考察硫酸核糖霉素中新霉胺的稳定性

Inspecting the Stability of Neamine in Ribostamycin Sulfate by HPLC

目的:考察硫酸核糖霉素(原料药)中杂质新霉胺的稳定性。方法:色谱柱为C18,流动相为水-冰醋酸-甲醇(25∶5∶70)配制的0.02mol/L庚烷磺酸钠溶液,流速为1.0ml/min,紫外检测波长为330nm。结果:将试验数据进行配对t检验(α=0.05),新霉胺杂质在60℃高温、强光照射条件下试验前后差异具有显著性意义;在40℃高温、高湿度条件下,试验前后差异无显著性意义。结论:新霉胺杂质在60℃高温、强光照射条件下不稳定;在40℃高温、高湿度条件下稳定。

OBJECTIVE：To investigate the stability of neamine（erude drug） ,a foreign material in ribostamyein sulfate by HPLC.METHODS： The separation was performed on C18 column, the mobile phase was 0.02mol/L sodium heptanesulfonate solution prepared with water- glacial acetic acid- methanol（25 ： 5 ： 70） with a flow rate of 1.0ml/ min and UV detection wavelength of 330nm.RESULTS： The experimental data were subjected to matched t test（α= 0.05）, as compared to the test before, there was significant difference after experiment for neamine（the foreign material） at 60℃ under highlight radiation; However, no significant difference was noted at 40℃ under high humidity condition before and after test.CONCLUSIONS： Neamine（foreign material） in unstable at 60℃ under highlight radiation while stable at 40℃ under high humidity condition.