ASSESSMENT OF CAPILLARY ELECTROPHORESIS IN PHARMACEUTICAL APPLICATIONS - ANALYSIS AND QUANTIFICATION OF A RECOMBINANT CYTOKINE IN AN INJECTABLE DOSAGE FORM

Several methods are available for determining the components present in a typical pharmaceutical dosage form. Although some of these methods are simple and have received wide pharmaceutical industry acceptance over many years, several limitations still need to be overcome. Capillary electrophoresis was examined as an alternative method for the determination of a recombinant cytokine in a pharmaceutical dosage form. The results show that capillary electrophoresis can separate the recombinant cytokine from its dosage form matrix adequately, rapidly and with minimum sample volume requirements. Owing to its high efficiency, high resolution and simplicity, capillary electrophoresis appears to be very applicable to pharmaceutical samples. For reliable quantification of the resulting data, however, it is essential to optimize the experimental conditions, such as separation buffer and capillary column temperature. The advantages and potential of capillary electrophoresis for the separation of active ingredients and excipients in pharmaceutical formulations are discussed.