RAPID AND SENSITIVE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF ITRACONAZOLE AND ITS HYDROXY-METABOLITE IN HUMAN SERUM

Published high performance liquid chromatographic (HPLC) methods for t he determination of itraconazole (ITZ) in biological matrices are labo r intensive, extraction-based procedures which operate at a pH approac hing the limit of column tolerance, and unless modified, cannot measur e its hydroxy-metabolite (OH-ITZ). A protein precipitation-based metho d requiring no solvent extraction and utilizing a base-deactivated C18 analytical column to minimize peak tailing is described herein. Calib ration curves for OH-ITZ and ITZ were linear from 25-1500 ng ml(-1) (r (2) greater than or equal to. 0.999). Intra-assay relative standard de viations (R.S.D.) were below 12%. Inter-assay R.S.D. were below 14%. T his method provides a rapid means for the accurate and precise determi nation of both OH-ITZ and ITZ concentrations in human serum. (C) 1998 Elsevier Science B.V. All rights reserved.