| 利用LC-MS和二维色谱相关光谱技术识别HPLC色谱图中杂质峰 |
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| 作者姓名： | Chen ZZ Zhang DS Wang N Feng F Hu CQ |
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| 作者单位： | 中国食品药品检定研究院;中国药科大学;江西省食品药品检验所 |
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| 基金项目： | 十一五重大新药创制资助项目(2010ZX09401-403) |
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| 摘 要： | 采用二维色谱相关光谱技术,实现质控HPLC方法与LC-MS色谱系统色谱峰的相互识别。本文采用HPLC-DAD(中国药典2010版方法)得到头孢唑肟和头孢地尼混合降解杂质的色谱图,建立降解杂质标准色谱光谱数据;采用LC-MS的方法结合MassWorks软件的应用鉴别出头孢唑肟和头孢地尼的主要降解产物;通过计算光谱相关性对杂质色谱峰进行归属。色谱二维光谱相关法在不同色谱系统下能够准确定性,在没有杂质对照品的情况下,可为质控HPLC方法中的杂质峰的归属提供新的途径和新的思路。
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| 关 键 词： | 二维色谱相关光谱技术 头孢唑肟 头孢地尼 |
Identification of impurity peaks in the HPLC chromatogram by LC-MS and two-dimensional chromatographic correlation spectroscopy |
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| Chen ZZ,Zhang DS,Wang N,Feng F,Hu CQ.Identification of impurity peaks in the HPLC chromatogram by LC-MS and two-dimensional chromatographic correlation spectroscopy[J].Acta Pharmaceutica Sinica,2012,47(4):492-497. |
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| Authors: | Chen Zhen-Zhen Zhang Dou-Sheng Wang Nan Feng Fang Hu Chang-Qin |
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| Institution: | National Institutes for Food and Drug Control, Beijing 100050, China. |
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| Abstract: | A novel qualitative analytical method by using two-dimensional chromatographic correlation spectroscopy techniques for recognizing impurity peaks of HPLC methods of quality control and LC-MS chromatographic system was established. The structures of major degradation products of ceftizoxime and cefdinir were identified by LC-MS and MassWorks application; the standard chromatographic and spectral data of the degradation impurities were obtained by high-performance liquid chromatography with diode array detection. The impurity peaks of two-dimensional chromatography were matched by comparison of spectra and calculating correlation coefficients. Peaks in chromatography can be identified accurately and rapidly in different chromatographic systems such as column and mobile phase changed. The method provides a new way and thought to identify the peaks in quality control of impurities without reference impurity substances. |
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| 本文献已被 CNKI PubMed 等数据库收录！ |
