Validated Assay for the Determination of Mitoxantrone in Pharmaceuticals Using Capillary Zone Electrophoresis

The first capillary zone electrophoretic (CZE) method for the determination of mitoxantrone (MTX) in pharmaceutical formulations was developed. The influence of background electrolyte (BGE) species, pH, concentration (cBGE), organic modifier, capillary temperature, applied voltage, and injection time was investigated. Optimum results were achieved with 25mM ammonium acetate at an apparent pH value of 5.0 in 50% v/v acetonitrile, applied voltage of+30kV, and capillary temperature of 25C. The samples were introduced into the capillary hydrodynamically for 2 s at 33.5 mbar. Mitoxantrone was detected at a wavelength of 242nm. Mitoxantrone and doxorubicin (DOX) (used as internal standard, ISTD) were completely separated in less than 7min. The method was suitably validated with respect to linearity, limits of detection (LOD) and quantification (LOQ), accuracy, precision, selectivity, and robustness. The proposed method was applied successfully for the determination of MTX in its injectable pharmaceutical formulation.