Bioequivalence study of baicalin capsules in healthy volunteers

AIM: To establish a HPLC-UV method for the study of pharmacokinetics and bioavailability of baicalin in human plasma. METHODS: The study was performed with 18 male volunteers according to a random 2-way cross-over design. Plasma samples of 18 male volunteers after oral administration of 750 mg baicalin test capsules and reference tablets were prepared by solid phase extraction and the concentrations of baicalin were determined by HPLC-UV method. Pharmacokinetic parameters were also estimated. RESULTS: The main pharmacokinetic parameters of baicalin test capsules and reference tablets were as follows: c_(max)(91±s 33)μg·L~(-1) and (86±29) μg·L~(-1), t_(max)(7.4±1.3) h and (7.4±1.0) h, AUC_(0-24)(586±233) μg·h·L~(-1) and(579±(173) μg·)h·L~(-1), AUC_(0-∞)(616±249) μg·h·L~(-1) and(613±180)μg·h·L~(-1), respectively. The relative bioavailability of baicalin test capsules was(101±(18) %). CONCLUSION: The HPLC-UV is proved to be simple, sensitive and rapid method showing the bio-( )equivalence of the two formulations.