DETERMINATION OF IMMUNOSUPPRESANT DRUGS IN PHARMACEUTICALS BY MICELLAR ELECTROKINETIC CAPILLARY CHROMATOGRAPHY

TRIPODI V.,; LUCANGIOLI S.,; RODRIGUEZ V.,; CARDUCCI C.

SAN PABLO, BRASIL

Simposio; IV SYMPOSSIUM ON BIOMEDICAL, BIOPHARMACEUTICAL AND INDUSTRIAL APPLICATION OF CAPILLARY ELECTROPHORESIS; 1998

Stringent requirements by regulatory agencies are targeted at the fine characterization of drug substances and finished drug products. Reliable and validated analytical tests are crucial and in growing demand in control laboratories to meet these regulatory rules. Our laboratory has focused in the development of analytical methods using micellar electrokinetic capillary chromatography to monitor the quality of cyclosporin in formula­tions. Cyclosporin A, a lipophilic cyclic undecapeptide, is an immunosuppressive agent widely used to prevent rejection in organ transplantation. The method showed to be selective for cyclosporine A and its degradation products. This drug has been assayed as raw material and in pharmaceutical dosage forms. Validation of the analytical pro­cedure following the international guidelines assured the reliability of the results.