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摘要
A high performance liquid chromatography (HPLC) method for the determination of voriconazole in human plasma samples has been developed and was applied to the therapeutic drug monitoring of voriconazole. The analytical column was packed with ZORBAX Eclipse XDB C18. A mixture of acetonitrile-0.1% trifluoroacetic acid-water (38:42:20) was used as the mobile phase with the flow rate at 1.0 ml/min. The column temperature was set at 35 degrees C. The detection wavelength was set at 258 nm. Carbamazepine was used as internal standard (IS), plasma was extracted by ethyl acetate under basic conditions. Excellent liner relationship was obtained from the range of 0.05 to 10.00 mu g/mL (r = 0.999 7). The lower limit of quantitation (LLOQ) was 0.05 mu g/mL, and no interferences were detected in the chromatograms. The chromatographic retention times of voriconazole and IS were 6.4 and 5.6 min, respectively. The intra-day RSDs were 4.53%, 3.58%, and 2.26% and inter-day RSDs were 5.10%, 3.62%, and 2.39%, respectively at three concentrations (0.25, 2.50, and 7.50 mu g/mL), the relative recoveries were 99.76 +/- 5.07%, 101.08 +/- 3.28%, and 100.15 +/- 2.48%, respectively. The method was successfully applied to the therapeutic drug monitoring of voriconazole in Chinese patients. Weight based voriconazole doses were prescribed to 36 patients for empirical treatment of invasive fungal infections. The method is simple, rapid, accurately and can be suitable for voriconazole clinical therapeutic drug monitoring. Routine TDM of voriconazole may reduce adverse events and improve the treatment response in invasive fungal infections.
