Nonaqueous capillary electrophoresis for the analysis of labile pharmaceutical compounds

A screening method using nonaqueous capillary electrophoresis (NACE) has been developed for purity analysis of pyridinyl-methyl-sulfinyl-benzimidazoles (PMSB). Eight different polar organic solvents were tested as background electrolytes. N-Methylformamide (NMF) was found to have the best properties in respect of both electrophoretic behavior and high solubility of five different model compounds. Optimization of the CE separation with regard to the effects of addition of various electrolyte modifiers is reported. An additional feature of amide solvents, rarely utilized in CE, is their intrinsic basic nature; this is of particular interest for analysis of compounds such as the PMSB, the degradation of which is acid-catalyzed. It is shown here that these compounds are stable at room temperature for weeks in NMF solution. Results from quantitative application of the NACE method were highly precise (typically 1.8 % RSD for normalized peak area); linearity was good and detection limit in drug purity determination was low (similar to 0.05 area % relative to the drug compound).