CE characterization of potential toxic labile iron in colloidal parenteral iron formulations using off-capillary and on-capillary complexation with EDTA.

The present study describes the application of CZE to investigate the portion of labile iron in the following parenteral formulations: iron gluconate, iron saccharate, and iron dextran. Labile iron was detected as Fe(III)-chelate of EDTA at 246 nm. When EDTA was incubated with the formulations before electrophoresis, labile iron, or chelatable iron, respectively, was detected in all formulations, mostly in iron gluconate and iron saccharate. It was observed that the amount of iron released is time- and pH-dependent. In contrast, when EDTA was separately injected before the formulation sharp peaks of the Fe(III)-chelate were detected only after injection of iron gluconate. This type of labile iron can be described as "electrophoretically free" iron. CE provides thus a new method to characterize potential toxic, labile iron in parenteral iron formulations.