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

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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

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作者：Qun Xu ; ^{qzx@usp.org" class="auth_mail" title="E-mail the corresponding author} ; Shane Tan ; Katya Petrova
关键词：Metoprolol succinate ; EP metoprolol impurity M ; EP metoprolol impurity N ; Hydrophilic interaction chromatography (HILIC) ; Charged aerosol detection/detector (CAD)
刊名：Journal of Pharmaceutical and Biomedical Analysis
出版年：2016
出版时间：25 January 2016
年：2016
卷：118
期：Complete
页码：242-250
全文大小：974 K

文摘

•: 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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