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Methods: Capillary electrophoresis (CE) was used for method development where micellar electrokinetic chromatography (MEKC) and free zone capillary electrophoresis (CZE) were the modes tested. In both modes sodium tetraborate buffer (TBNa) and uncoated fused-silica were used for analysis. For MEKC mode analysis, sodium dodecyl sulfate was used to form micelles and improve separation resolution. In CZE experiments, samples were analyzed in two ways: only with buffer and adding different concentrations of diamine, a capillary wall modifier, in order to promote vaccine components separation. Different parameters such as: temperature, electric current, voltage, buffer concentration, pH and sample volume were tested in both CE modes. Vaccine conjugate bulk (MPCT), hidrazide-activated monomeric tetanus toxoid (MATT), MPCT spiked with MATT and oxidized meningococcal C polysaccharide (MPCO) samples were introduced into capillary using MEKC and CZE modes, in order to obtain optimum separation resolution and evaluate method selectivity.

Development of capillary electrophoresis method for determining free protein content in a brazilian meningococcal C conjugate vaccine