色谱二维光谱相关法识别莫西沙星中的杂质

Identification of impurities in Moxifloxacin by chromatographic two-dimensional spectroscopy correlation

目的建立识别HPLC色谱图中莫西沙星杂质色谱峰的色谱二维光谱相关方法。方法采用高效液相色谱-二极管阵列检测器(HPLC-DAD),建立杂质标准色谱光谱数据;通过样品的色谱光谱数据与标准色谱光谱数据的二维相似计算,对杂质进行识别。结果色谱二维光谱相关法在不同色谱系统下均能准确定性,对样品中杂质判断结果与质谱法一致,识别的最低检出限为30 ng。结论色谱二维光谱相关法可有效地对HPLC分析中的色谱峰进行识别,具有准确度高、耐用性好、多组分同时快速定性的特点,适用于归属因色谱柱、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。

OBJECTIVE To establis a qualitative analysis method to identify related substances of Moxifloxacin by correlation of spectra in chromatography. METHODS Standard chromatographic and spectral data obtained by high - performance liquid chromatograpy with diode army detection（HPLC - DAD） were developed and used in identification of peaks in samples by calculating correlation coefficients. RESULTS Peaks in chromatography can be identified accurately and rapidly through chromatographic system such as column and mobile phase change. The liufit amount for identification was 30 ng. CONCLUSION The method is accurate and reproducible as a new and effective way to identify multi- components in drugs when relative retention times are incapable due to changes of chromaatographic system.