| 高效液相色谱法考察硫酸核糖霉素中新霉胺的稳定性 |
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| 引用本文： | 鲁继光,顾晔. 高效液相色谱法考察硫酸核糖霉素中新霉胺的稳定性[J]. 中国药房, 2006, 17(7): 533-535 |
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| 作者姓名： | 鲁继光 顾晔 |
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| 作者单位： | 1. 江苏苏州九龙医院,苏州市,215021
2. 江苏无锡市第二制药厂,无锡市,214042 |
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| 摘 要： | 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。
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| 关 键 词： | 高效液相色谱法 硫酸核糖霉素 新霉胺 稳定性 |
| 文章编号： | 1001-0408(2006)07-0533-03 |
| 收稿时间： | 2005-04-25 |
| 修稿时间： | 2005-06-04 |
Inspecting the Stability of Neamine in Ribostamycin Sulfate by HPLC |
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| LU Jiguang,GU Ye. Inspecting the Stability of Neamine in Ribostamycin Sulfate by HPLC[J]. China Pharmacy, 2006, 17(7): 533-535 |
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| Authors: | LU Jiguang GU Ye |
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| Affiliation: | 1. Suzhou Jiulong Hospital in Jiangsu Province,Suzhou 215021,China; 2. Wuxi No. 2 Pharmaceutical Co. Ltd, Wuxi 214042, China |
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| Abstract: | OBJECTIVE:To investigate the stability of neamine(crude drug),a foreign material in ribostamycin sulfate by HPLC.METHODS:The separation was performed on C 18 column,the mobile phase was0.02mol/L sodium heptanesulfonate solution prepared with water-glacial acetic acid-methanol(25∶5∶70)with a flow rate of1.0ml/min and UV detection wavelength of330nm.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)at60℃under highlight radiation;However,no significant difference was noted at40℃under high humidity condition before and after test.CONCLUSIONS:Neamine(foreign material)in unstable at60℃under highlight radiation while stable at40℃under high humidity condition. |
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| Keywords: | HPLC Ribostarhycin Sulfate Neamine Stability |
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