RP-HPLC determination of erdosteine in human plasma and its pharmacokinetic studies

Objective:To establish an HPLC method for the determination of erdosteine plasma concentrations in 20 healthy volunteers and to study its pharmacokinetics.Methods:A single dose of 600 mg erdosteine dispersing tablets or capsules was given to 20 healthy volunteers in a two-way cross-over design.The plasma were collected and the concentrations of erdosteine were determined by RP-HPLC method using Luna C_(18)(2)(150 mm×4.6 mm,5μm) column and mobile phase of methanol-sodium acetate at flow rate of 0.7 mL·min~(-1),and the detection wavelength was 236 nm.Results:The limit of detection for erdosteine was 0.01μg·mL~(-1),and the linearity obtained in the range of 0.01-3μg·mL~(-1)was good(r=0.9991).The relative standard deviations of intra-day and inter-day determination were less than 5%.The main pharmacokinetic parameters of erdosteine dispersing tablets and cap- sules were as follows:t_(1/2)(h),2.478±1.206 and 2.603±1.282;T_(max)(h),1.163±0.424 and 1.413±0.424; C_(max)(μg·mL~(-1)),1.419±0.385 and 1.594±0.558;AUC_(0-12)(μg·mL~(-1)·h),3.416±1.037 and 3.433± 0.910;AUC_(0-∞)(μg·mL~(-1)·h),3.492±1.044 and 3.523±0.912,respectively.Conclusions:The method is sensitive,fast and accurate,and can be successfully used for the determination of erdosteine plasma concentration and for its pharmacokinetie studies.The statistic analysis shows that erdosteine dispersing tablets and capsules are bioequivalent.