Capillary electrophoresis for regulatory analysis: is it ready? Problems encountered during an interlaboratory study utilizing capillary electrophoresis

Recently, the Northeast Regional Laboratory of the Food and Drug Administration conducted a collaborative study on the method to determine histamine in tuna by capillary electrophoresis. This study, under the guidance of the AOAC International, was the first of its kind involving the use of CE and was undertaken to establish official monograph status. The results of the collaborative study, however, were highly variable. Percent recovery data obtained by 11 collaborators ranged from 54 to 281%, with an average of 111%. In this paper, problems with reproducibility, and factors such as low sensitivity, noisy baselines, and variable migration times encountered by collaborators using various commercial capillary electrophoresis units are discussed.