| HPLC法测定注射用替卡西林钠克拉维酸钾的有关物质 |
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| 引用本文： | 陈颖,傅嘉华,周丽梅. HPLC法测定注射用替卡西林钠克拉维酸钾的有关物质[J]. 中国医药导报, 2010, 7(21): 49-50 |
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| 作者姓名： | 陈颖 傅嘉华 周丽梅 |
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| 作者单位： | 1. 广东食品药品职业学院,广东广州,510520
2. 广州白云山天心药业股份有限公司,广东广州,510000 |
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| 摘 要： | 目的：建立HPLC法测定注射用替卡西林钠克拉维酸钾有关物质的方法。方法：采用氰基硅烷键合硅胶（4.6mm×250mm,5μm）色谱柱;流动相：0.1mol/L磷酸二氢钠溶液（pH=3.25）-异丙醇（97.5：2.5）;检测波长：230nm;流速：1.0ml/min。结果：各杂质峰与主峰分离度良好,克拉维酸的最小检测限为0.193μg/ml,替卡西林的最小检测限为0.355μg/ml。结论：本方法可用于注射用替卡西林钠克拉维酸钾的有关物质检测,且方法简便快速、准确可靠。
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| 关 键 词： | 替卡西林钠 克拉维酸钾 有关物质 |
Determination of related substances in Ticarcillin disodium and Potassium Clavulanate for Injection by HPLC |
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| CHEN Ying,FU Jiahua,ZHOU Limei. Determination of related substances in Ticarcillin disodium and Potassium Clavulanate for Injection by HPLC[J]. China Medical Herald, 2010, 7(21): 49-50 |
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| Authors: | CHEN Ying FU Jiahua ZHOU Limei |
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| Affiliation: | 1.Guangdong Food and Drug Vocational College,Guangzhou 510520,China;2.Guangzhou Baiyunshan Tianxin Pharma ceutical Co.,Ltd.,Guangzhou 510000,China) |
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| Abstract: | Objective：To establish a method for determination Ticarcillin disodium and Potassium Clavulanate for Injection by HPLC.Methods：The Macherey-nagel（4.6 mm×250 mm,5 μm） column was used.The mobile phases consisted of 0.1mol/L-sodium dihydrogen phosphate（pH=3.25） and propanol（75：25）,the detection wavelength was 230 nm and the flow rate was 1.0 ml/min.Results：Impurities were separated well from the main constituents,and the detection limit of potassium clavulanate was 0.193 μg/ml and the detection limit of ticarcillin disodium was 0.355 μg/ml.Conclusion：This method is suitable for the quality of Ticarcillin disodium and Potassium Clavulanate for Injection,and the method is simple,rapid,accurate. |
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| Keywords: | Ticarcillin disodium Potassium Clavulanate Related substances |
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