Pharmacokinetics Study of a Single Dose Gatifloxacin Mesylate Capsule in Healthy Volunteers

Aim To establish an HPLC method for the plasma concentration of gatifloxacin and investigate its pharmacokinetic features in healthy volunteers.Methods Shim-pack CLC-ODS C 18 (150mm×6mm,5μm) spectrum analytical column was used.Methanol-water-sodium lauryl sulfate (500ml∶500ml∶3.5g,pH=3.0) was adopted as the mobile phase and Flow rate was adjusted at 1.0ml/min with detection wavelength at 292nm.Results HPLC showed that the plasma concentration of gatifloxacin was well in linearity within the ranges of 0.15～9.92μg·ml -1 and the correlation coefficient is 0.999.The limit of detection in plasma was 20ng·ml -1 .The average recovery of the present method was 96.40%～97.21%.The coefficients of inter-day and intra-day variations were 1.02%～5.56% and 1.64%～7.34% respectively.The results showed that the pharmacokinetics of gatifloxacin was in line with the one-compartment open model.The values of T max 、C max 、T 1/2(Ke) 、AUC (0-24h) were (1.604±0.419)h,(3.715±0.424)μg·ml -1 ,(6.142±0.684)h and (36.568±5.522)μg·h·ml -1 respectively.Conclusion Effective concentration in po can be achieved after one dose of 400mg gatifloxacin mesylate per day.The method is accurate and rapid.It can be used to study pharmacokinetics of gatifloxacin mesylate and to monitor the plasma drug concentration.