Capillary electrophoresis determination of loratadine and related impurities.

While HPLC has traditionally been the method of choice for purity determination of pharmaceutical substances, capillary electrophoresis (CE) offers a different selectivity and hence it is a complementary technique to HPLC. Loratadine, an antihistamine, could include in its raw material seven impurities that ought to be separated, identified and quantified for drug development and quality control. As a complementary tool for undoubtful identification, a CE method has been developed. The separation was carried out with an uncoated fused-silica capillary (57 cm x 50 microm ID) and was operated at 20 kV potential. Temperature was maintained at 25 degrees C. The final separation buffer was prepared with 100 mM H(3)PO(4) made up to pH 2.5 with NaOH and with 10% acetonitrile added (v/v). Impurities can be detected at the 0.1% level of the active and validation parameters for linearity accuracy and precision are adequate for all the analytes and that permits to consider the method reliable and suitable for application to long-term stability and purity studies.