| HPLC法测定甲磺酸培氟沙星及其注射剂有关物质 |
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| 引用本文： | 曾杰,朱晓璐,王刚林. HPLC法测定甲磺酸培氟沙星及其注射剂有关物质[J]. 中国当代医药, 2010, 17(27): 59-60 |
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| 作者姓名： | 曾杰 朱晓璐 王刚林 |
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| 作者单位： | 1. 重庆市药品检验所,重庆,401121
2. 重庆市医疗器械检测中心,重庆,401121 |
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| 摘 要： | 目的：建立HPLC法测定甲磺酸培氟沙星及其注射剂有关物质。方法：C18色谱柱,流动相为乙腈-2.70g/十六烷基三甲基溴化铵与6.18g硼酸溶液的混合溶液（用1mol/L氢氧化钠溶液调pH值至8.30）-硫二甘醇（30∶70∶0.2）,检测波长为273nm。结果：培氟沙星与同系物及相关杂质分离良好。结果：本方法结果准确、专属性强,更适用于甲磺酸培氟沙星有关物质的检测。
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| 关 键 词： | 甲磺酸培氟沙星 高效液相色谱 有关物质 |
Determination of related substance in pefloxacin mesylate and pefloxacin mesylate for injection by HPLC |
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| ZENG Jie,ZHU Xiaolu,WANG Ganglin. Determination of related substance in pefloxacin mesylate and pefloxacin mesylate for injection by HPLC[J]. http://www.botanicus.org/, 2010, 17(27): 59-60 |
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| Authors: | ZENG Jie ZHU Xiaolu WANG Ganglin |
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| Affiliation: | 1.Chongqing Institutefor Durg Control, Chongqing 401121, China; 2. Chongqing Testing Center for Medical Equipments, Chongqing 400121, China) |
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| Abstract: | Objective： To establish a method for the related substance of pefloxacin meylate and Pefloxacin Mesylate for Injection by HPLC. Methods： The analysis was conducted by HPLC using a Cl8 colmnn. The mobile phase was aeetonitrile-mixture of 2.70 g/L eetyhrimethylammonium bromide with 6.18 g/L boric acid solution （adjusted to pH 8.30 with 1 mol/L sodium hydroxide）-2, 2-thiodiglycol （30∶70∶0.2）. The detection wavelength was set at 273 nm. Results： The resolution between the respective peaks of pefloxacin mesylate with the other peaks conformed to the requirements. Conclusion： The method is simple, accurate and specific, and reproducible for the related substance of pefloxacin mesylate and Pefloxacin Mesylate for Injection. |
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| Keywords: | Pefloxacin mesilate HPLC Related substance |
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