Multiple heart-cutting two dimensional liquid chromatography mass spectrometry: Towards real time determination of related impurities of bio-pharmaceuticals in salt based separation methods.

摘要: Abstract Many of the chromatographic methods used in industry to determine related impurities bio pharmaceuticals employ salt containing mobile phases. “Salty” phases often provide superior performance but are not compatible with mass spectrometry (MS) detection. Peak tracking necessary for method development is therefore based on peak areas and chemist’s experience/intuition. In addition, MS characterization usually done by offline fraction collection, which apart from being time consuming suffers poor recovery or degradation collected. The recent multiple heart-cutting (MHC) two-dimensional liquid chromatography (2D-LC) provides a way address these problems. This study shows how MHC 2D-LC–MS can be obtain almost real data bovine insulin present at low level (