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色谱相关光谱法识别莫西沙星HPLC分析中的有关物质色谱峰
引用本文:李玮,胡昌勤,杭太俊,田颂九.色谱相关光谱法识别莫西沙星HPLC分析中的有关物质色谱峰[J].中国药学杂志,2006,41(8):627-630.
作者姓名:李玮  胡昌勤  杭太俊  田颂九
作者单位:1. 中国药品生物制品检定所,北京,100050;安徽省药品检验所,合肥,230061
2. 中国药品生物制品检定所,北京,100050
3. 中国药科大学分析测试中心,南京,210009
摘    要: 目的建立识别HPLC色谱图中莫西沙星有关物质色谱峰的色谱相关光谱方法。方法采用高效液相色谱-二极管阵列检测器(HPLC-DAD),提取各有关物质峰的标准光谱,建立有关物质标准光谱库;通过计算莫西沙星有关物质色谱峰的光谱与标准光谱库中光谱的相似系数,对有关物质进行识别。结果光谱识别的最低检出限为20 ng,相似系数阈值为0.995。结论色谱相关光谱法可有效地对HPLC分析中的色谱峰进行识别,具有专属性强,准确度高,耐用性好的特点,适用于对由于色谱柱、流动相等色谱条件的改变,无法利用相对保留时间定性的色谱峰的归属。

关 键 词:高效液相色谱法  色谱相关光谱  莫西沙星  有关物质  鉴别
文章编号:1001-2494(2006)08-0627-05
收稿时间:2005-07-18
修稿时间:2005-07-18

Identification of Related Substances of Moxifloxacin by Spectra Correlation in Chromatography
LI Wei,HU Chang-qin,HANG Tai-jun,TIAN Song-jiu.Identification of Related Substances of Moxifloxacin by Spectra Correlation in Chromatography[J].Chinese Pharmaceutical Journal,2006,41(8):627-630.
Authors:LI Wei  HU Chang-qin  HANG Tai-jun  TIAN Song-jiu
Institution:1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China; 2. Anhui Institute for Drug Control, Hefei 230061, China; 3. Center for Instrumental Analysis, China Pharmaceutical University, Nanjing 210009, China
Abstract:OBJECTIVE To develop a qualitative analysis method to identify related substances of moxifloxacin by the correlation of spectra in chromatography.METHODS The UV spectra of four related substances in moxifloxacin were measured by high-performance liquid chromatography with diode array detection(HPLC-DAD).The standard spectra of the related substances and their spectral correlative chromatography were developed and used in identification by calculating correlation coefficients.RESULTS The threshold of correlation coefficients was 0.995 and the limit amount for identification was 20 ng. CONCLUSION The method is accurate and reproducible as a new and effective way to identify impurities in drugs when relative retention times are incapable due to the changes of chromatographic system such as column or mobile phase.
Keywords:HPLC  spectra correlation in chromatography  moxifloxacin  related substances  identification
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