| LC-MS／MS 法分析注射用头孢唑林钠中的有关物质 |
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| 引用本文： | 刘忠莹,杨鹏博,黄晓军,狄斌,陈金龙. LC-MS／MS 法分析注射用头孢唑林钠中的有关物质[J]. 新疆医科大学学报, 2014, 0(12): 1608-1613 |
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| 作者姓名： | 刘忠莹 杨鹏博 黄晓军 狄斌 陈金龙 |
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| 作者单位： | 1. 中国药科大学药物分析教研室,南京,210009
2. 深圳立健药业有限公司,广东 深圳,518109 |
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| 基金项目： | 国家自然科学基金(81173022)；新疆维吾尔自治区自然基金 |
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| 摘 要： | 目的：建立对注射用头孢唑林钠中有关物质进行定性分析的 LC-MS/MS 法。方法采用 Phenome-nex ODS（250 mm×4．6 mm，5μm）为色谱柱；10 mmol 醋酸铵水溶液为流动相 A，乙腈为流动相 B 的挥发性流动相线性梯度洗脱。采集有关物质的 PDA 谱、质谱母离子及子离子谱，并进行结构解析，推测有关物质的结构。结果在所建立的条件下，注射用头孢唑林钠中有关物质分离良好，检出11个有关物质峰。结论本文建立的LC-MS/MS 法可有效地分离分析注射用头孢唑啉钠中的有关物质，并为其质量控制和工艺纯化提供技术参考。
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| 关 键 词： | 注射用头孢唑林钠 有关物质 液相色谱串联质谱法 分离 鉴别 |
Identification of the Cefazolin sodium for injection by LC-MS/MS |
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| LIU Zhongying,YANG Pengbo,HUANG Xiaojun,DI Bin,CHEN Jinlong. Identification of the Cefazolin sodium for injection by LC-MS/MS[J]. Journal of Xinjiang Medical University, 2014, 0(12): 1608-1613 |
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| Authors: | LIU Zhongying YANG Pengbo HUANG Xiaojun DI Bin CHEN Jinlong |
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| Affiliation: | LIU Zhongying, YANG Pengbo , HUANG Xiaojun , DI Bin, CHEN Jinlong(1 Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China 2 Shenzhen Lijian Pharmaceutical Co., Ltd. China, Shenzhen Guangdong 518109, China) |
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| Abstract: | Objective To establish the identification of the related substances in Cefazolin sodium for injec-tion by LC-MS/MS method.Methods High pressure/performance liquid chromatography （HPLC）sepa-ration was carried out on Phenomenex ODS （250×4.6 mm,5 μm）with a gradient mobile phase consisting of 10 mmol/L ammonium acetate and pure acetonitrile.The PDA,parent ions and the corresponding prod-uct ions spectra of all the related substance in Cefazolin sodium for injection were determined.Results Good resolution of Cefazolin sodium and their main related substances were achieved.Eleven related sub-stances in Cefazolin sodium for injection were detected by LC-MS/MS.Conclusion The established method is effective in the separation and identification of the related substances in Cefazolin sodium for in-jection and the results are useful for its quality control. |
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| Keywords: | Cefazolin sodium for injection related substances LC-MS/MS analysis determination |
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