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LC/LC/MS Method to obtain trace impurity profiles for process authentication

A chromatographic method based on liquid chromatography to obtain trace impurity profiles has been developed.

The method is based on either a LC-LC-MS or LC-LC-UV system: it consists in injecting a highly concentrated solution on a short column called “preconcentration column”, in order to eliminate the main product. Impurities in the solution containing the sample are then eluted from this short column towards an analytical column where chromatographic separation occurs. Two types of detectors are connected to the outlet of the analytical column:
UV-Vis and mass spectrometers. This enables peaks to be recognised by both retention time and molecular mass.

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