AIM: To determine gemfibrozil in human plasma by HPLC method, and study its
pharmacokinetics and relative bioavailability. METHODS: Twenty volunteers were randomly divided into 2 groups. Group Ⅰ first received the trial
preparation gemfibrozil capsules, and then followed by the reference preparation, while Group Ⅱ received the reference preparation first, and followed by the trial preparation. Plasma concentration of gemfibrozil was measured by high performance liquid
chromatography (HPLC) method. ANOVA was used to check the difference of the means of the
Pharmacokinetic parameters between the two preparations. Bioequivalence was determined by two one-sided t-tests. RESULTS: The pharmacokinetic parameters, AUC 0-10, AUC 0-∞, c max, t max and t 1/2 of the volunteers after taking a single dose of 600 mg of the trial preparation or the comparison preparation were (93±17) and (93±18) mg·h·L -1, (95±17) and (96±19) mg·h·L -1, (31±8) and (31±8) mg·L -1, (1.6±0.4) and (1.5± 0.5) h, respectively. The relative
bioavailability was(100±11)%. No significant differences were found among the main pharmacokinetic parameters after the ANOVA. CONCLUSION: The methods can determine gemflbrozil concentration in the human plasma quickly and correctly. The two preparations were equivalent.
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