water oasis

water oasis

Currently, the FDA is carefully considering the impact of matrix effects on LC/MS analysis as part of an overall review of quantitative bioanalysis. Following the Crystal City III meeting, several pharmaceutical industry leader groups met and produced  to explain the FDA recommendations regarding matrix effects. 

Over the last decade, the combination of LC and MS technologies has become a widely accepted practice for determining and quantifying specific analytes in complex biological matrices. Consequently, matrix interaction with the analyte(s) in the MS ion-source introduced new variability in quantitative analysis not seen with UV detection. This interaction was found to result in one of two phenomena: ion suppression or ion enhancement. Both may lead to variability that adversely impacts assay linearity, LLOQ reproducibility, and/or ultimately LC/MS assay validation. 

Protocols using  SPE products have been well documented and proven to limit matrix-induced ion suppression/enhancement. They efficiently remove matrix components (e.g. phospholipids) that lead to analytical variability, via a high-quality sample cleanup.