Development of a Robust Method for Analysis of Aspirin and Related Substances Using a Statistical Software and Quality-by-Design Approach

资料库号码:
APNT135082347
部件代码:
720007177EN
作者:
Margaret Maziarz, Paul D. Rainville, Tran Pham
消息来源:
Waters
内容类型:
应用文章
内容子类型:
应用纪要
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In this application note, we develop a MS compatible method for aspirin API and its related substances using a Fusion QbD method development software. Fusion QbD method development software is applied to perform DoE studies, statistical data analysis, and mathematical modeling for an optimum and robust method. Experiments are run on an ACQUITY Arc System integrated with PDA and ACQUITY QDa detectors, controlled by Empower Data Chromatography Software (CDS). The final method separates all analytes of interests using MS compatible mobile phase and is suitable for the analysis of aspirin tablet formulations. 


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