Development and validation of a hydrophilic interaction chromatography method coupled with a charged aerosol detector for quantitative analysis of nonchromophoric α-hydroxyamines, organic impurities of metoprolol.
Journal of Pharmaceutical and Biomedical Analysis(2016)
摘要
•The first report of a quantitative HPLC method for metoprolol EP impurities M and N.•HILIC method development including a comprehensive HILIC column screening.•The HILIC-CAD method showed good linearity, sensitivity, specificity, accuracy and precision.•Application of a HILIC-CAD method for the analysis of polar, nonochromophoric α-hydroxyamines in metoprolol drug substances and drug products.
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关键词
Metoprolol succinate,EP metoprolol impurity M,EP metoprolol impurity N,Hydrophilic interaction chromatography (HILIC),Charged aerosol detection/detector (CAD)
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