Evaluating the utility of ion mobility separation in combination with high-pressure liquid chromatography/ mass spectrometry to facilitate detection of trace impurities in formulated drug products
作者： Christine Eckers , Alice M.-F. Laures , Kevin Giles , Hilary Major , Steve Pringle
DOI: 10.1002/RCM.2938
关键词:
摘要: Many formulated products contain complex polymeric excipients such as polyethylene glycols (PEGs). Such can be readily ionized by electrospray and may present at very high concentrations, thus making it difficult to identify trace level impurities degradants in samples, even if hyphenated techniques liquid chromatography/mass spectrometry (LC/MS) are used. Ion mobility (IM) is a rapid gas-phase separation technique offers additional capability within the LC timeframe. This work investigates use of an IM separator combination with high-pressure chromatography (HPLC) MS, improve drug-related materials from excipients, aiding identification trace-level anti-HIV medication, Combivir.
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