| 头孢曲松钠降解试验及降解产物的结构鉴定 |
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| 引用本文： | 于佳,杨利红,胡昌勤,严拯宇.头孢曲松钠降解试验及降解产物的结构鉴定[J].中南药学,2014(2):106-109. |
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| 作者姓名： | 于佳 杨利红 胡昌勤 严拯宇 |
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| 作者单位： | [1]中国药科大学,南京210009 [2]黑龙江省食品药品检验检测所,哈尔滨150001 [3]中国食品药品检定研究院,北京100050 |
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| 基金项目： | 国家科技重大专项子课题（No.2011ZX09303-001） |
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| 摘 要： | 目的筛选并确定头孢曲松钠混合杂质对照品的制备条件。方法通过强制降解试验,得到头孢曲松钠混合降解产物;采用UPLC-Q-TOF-MS法,对混合降解产物中各成分进行鉴定。结果在所建立的条件下,头孢曲松钠及其降解产物得到有效的分离。混合降解产物中各成分包括头孢曲松钠的工艺杂质:三嗪环(杂质C)、脱乙酰氧基头孢噻肟内酯(杂质B)、7-ACT(杂质E);降解杂质:β-内酰胺开环产物、C-3或C-8位侧链断键产物和异构体。结论混合降解产物中综合了工艺杂质和降解杂质,可作为混合杂质对照品应用于系统适用性试验中,评价色谱系统的分离效果。
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| 关 键 词： | 头孢曲松钠 降解产物 LC-MS |
Degradation test of ceftriaxone sodium and structure identification of its degradation products |
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| Institution: | YU Jia;YANG Li-hong;HU Chang-qin;YAN Zhen-yu;China Pharmaceutical University;Heilongjiang Institute for Food and Drug Control;National Institute for Food and Drug Control; |
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| Abstract: | Objective To select and determine the preparation conditions of ceftriaxone sodium mixed impurity reference substance. Methods Mixed degradation products were obtained by forced degradation test. Each component was identified by UPLC-Q-TOF-MS. Results The method could be used for the separation of the degradation products of celftriaxone sodium. Mixed degradation products included process impurities of ceftriaxone sodium： triazine（impurity C）, deacetylcefotaxime lactone（impurity B）, 7-ACT（impurity E） and degradated impurities： beta lactam ring-opening products, C-3 or C-8 side chain broken products and isomer. Conclusion Mixed degradation products including process impurities and degradation impurities can be used as reference substance of system applicability test to evaluate the chromatographic separation of the system. |
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| Keywords: | ceftriaxone sodium degradation product LC-MS |
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