Title: Determination of Fluconazole and its Relative Bioavailability in Human Plasma by HPLC-MS
Abstract: OBJECTIVE To establish a high performance liquid chromatography-electrospray mass spectrometry method for the determination of fluconazole in human plasma and to study the pharmacokinetics and bioequivalence of fluconazole in healthy volunteers.METHODS After being deproteined by methanol the fluconazole concentration in plasma was determined by HPLC-MS method with metronidazole for the internal standard.A randomized crossover design was performed in 20 healthy volunteer.In the study periods,a single 150 mg dose of each capsule was administered to each volunteer.The main pharmacokinetic parameters and relative bioavailability were calculated to evaluate the bioequivalence of 2 preparations.RESULTS AUC_(0-120) of tested fluconazole capsule and reference fluconazole capsule were(121.59±12.79)and(115.01±13.44)μg·h·mL~(-1),C_(max)were(3.09±0.29) and(3.18±0.33)μg·h·mL~(-1),T_(max)were(2.6±1.1) and(2.3±1.0)h,t_(1/2)were(31.67±4.33) and(30.99±4.95)h,respectively,and the relative bioavalability of the test capsule was(106.4±11.8)%.The main pharmacokinetic parameters obtained showed no statistically significant difference between 2 products.CONCLUSION The assay is proved to be sensitive,accurate,and convenient.The reference and test formulation are bioequivalent.
Publication Year: 2005
Publication Date: 2005-01-01
Language: en
Type: article
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