Abstract
A capillary electrophoretic method (CE) was developed for determining the purity of the novel metal chelator TMT-NCS. The separation of TMT-NCS from its degradation products, synthetic intermediates and by-products was accomplished using free solution CE in an aqueous-organic solvent system. This compound exhibits a complex impurity profile with the potential for over 30 degradants/impurities. The CE separation was optimized with respect to buffer type and concentration, pH, organic solvent and competitive chelator additive, allowing the resolution of all impurities in under 20 min. The specificity was established by examining stressed samples and evaluating peak purity using a diode-array detector. The sensitivity for low level impurities was optimized using sample stacking. Preliminary validation data were accumulated to support the utility of this method for estimating the purity of this drug intermediate.
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