反相离子对高效液相色谱法测定威替米星的稳定性

Stability study of vertilmicin by reversed phase ion-paring high performance liquid chromatography

目的:对威替米星原料药的稳定性进行研究。方法:将威替米星原料药置于不同条件下考察其稳定性,采用反相离子对高效液相色谱法对稳定性放置样品的含量及有关物质进行检测。结果:本品经高温试验[(60.0±s2.0)℃]10d,高湿度试验[相对湿度(75±5)%]10d,加速试验[相对湿度(75±5)%,(40.0±2.0)℃]6mo,长期试验[相对湿度(60±5)%,(25.0±2.0)℃]12mo,原料药的颜色外观略有变化,有关物质及含量均无明显变化,在合格范围之内。但高湿条件下5,10d样品,原料药吸湿严重,含量有所下降。结论:本品在长期放置条件下稳定性良好,但有引湿性,应置于密闭容器、干燥环境中保存。

AIM:To perform stability study of vertilmicin substances. METHODS:Placing ve r tilmicin substances under different conditions for stability study with revesed phase ion-paring high performance liquid chromatography to determine the conte nt and impurity of the stable sample. RESULTS:During high-temperature testing for 10 d, high-humidity testing for 10 d, acceleration testing for 6 mo and lo ng-term testing for 12 mo, there were no significant changes found except for se vere moisture absorption outcoming with certain decrease of content during high -humidity testing. CONCLUSION:Vertilmicin is stable during the stability study but it must be kept in a dry circumstance because of hygroscopy.