Abstract: AIM:To establish a HPLC method for the determination of levofloxacin in plasma and to investigate the pharmacokinetics of levofloxacin hydrochloride soft capsules, hard capsules and tablets in Chinese healthy volunteers.METHODS:20 male healthy subjects were received a single oral dose of 200 mg/Levofloxacin. The concentrations of levofloxacin in plasma were determined by HPLC.RESULTS: The linear range of levofloxacin was between 0. 041 mg/L and 5. 18 mg/L. The inter-day and intra-day RSD were less than 5% .The main pharmacokinetic parameters of levofloxacin soft capsule were as follows: t_max: (0. 8 ±0. 3) h, C_max: (2. 8 ± 0. 9) mg/L, AUC0-30: (14. 7 ± 1. 8) mg·L^-1 ·h, AUC_0-∞: (15. 4 ±1. 9) mg·L^-1·h, t_1/2: (6. 9 ±0. 4) h. There were no statistically significant differences among the main pharmacokinetic parameters of levofloxacin hydrochloide soft capsule hard capsule and tablet.CONCLUSION:The main pharmacokinetic parameters of levofloxacin hydrochloride soft capsules were similar to those of hard capsule and tablet.

Key words: levofloxacin hydrochloride, soft capsule, HPLC, pharmacokinetics