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| 法罗培南钠中有关物质测定方法的建立 | |
| 引用本文： | 赵霞,胡昌勤,金少鸿. 法罗培南钠中有关物质测定方法的建立[J]. 中国药学杂志, 2005, 40(5): 385-387 |
| 作者姓名： | 赵霞 胡昌勤 金少鸿 |
| 作者单位： | 中国药品生物制品检定所,北京,100050 |
| 摘 要： | 目的 建立使用HPLC测定法罗培南钠中有关物质的方法。方法 Agilent Zorbax Eclipse XDB-C18色谱柱(4.6mm×150mm,5μm),以0.02mol·L-1三乙胺三氟醋酸缓冲液(取三乙胺2.7mL,加水至900mL,用三氟醋酸调节pH2.5后,加水稀释至1000mL)-乙腈(86∶14)为流动相,检测波长247nm,流速:1.0mL·min-1,柱温 :40℃。结果 样品中各成分的分离度及检出灵敏度完全满足有关物质限度的测定要求。最小检出量为2.4ng。结论 本法简便、专属、能有效控制产品的质量。 |
| 关 键 词： | 法罗培南钠 有关物质 高效液相色谱法 |
| 文章编号： | 1001-2494(2005)05-0385-03 |
| 收稿时间： | 2004-07-20; |
A HPLC method for determination of related substances of faropenem sodium |
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| ZHAO Xia,HU Chang-qin,JIN Shao-hong. A HPLC method for determination of related substances of faropenem sodium[J]. Chinese Pharmaceutical Journal, 2005, 40(5): 385-387 | |
| Authors: | ZHAO Xia HU Chang-qin JIN Shao-hong |
| Affiliation: | National Institute for the Control of Pharmaceutical and Biological Products，Beijing 100050，China |
| Abstract: | OBJECTIVE To develop a HPLC method for determination of related substances of faropenem sodium.METHODS Faropenem sodium and its related substances were separated by using a mobile phase consisted of acetonitrile-0.02 mol·L-1 triethylamine(14∶86,pH2.5) at a flow rate of 1.0mL·min-1on an Aglient Zorbax Zclipse XDB-C18 column and detected at 247 nm.RESULTS The resolution and sensitivity of related substances were acceptable.The detection limit was 2.4 ng.CONCLUSION This method was found to be simple and selective It could be used to control the quality of product effectively. |
| Keywords: | faropenem sodium related substances HPLC |
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