[Reversed phase high-performance liquid chromatography for determination of plasma olanzapine and pharmacokinetics of olanzapine in healthy Chinese volunteers].

ABSTRACT

OBJECTIVE: To establish a reversed phase high-performance liquid chromatography (HPLC) system for determining plasma concentration of olanzapine and analyze the pharmacokinetics of olanzapine in healthy Chinese volunteers. METHODS: Ten healthy male subjects received a single oral dose of 20 mg olanzapine tablets. The plasma concentrations of olanzapine were determined by HPLC, and the data were analyzed using 3P97 program. RESULTS: The plasma concentration curve of olanzapine following a single oral dose conformed to the two compartment open model. The main pharmacokinetics parameters of olanzapine were as follow C(max) was 113.7-/+33.1 microg/L, T(max) 5.07-/+0.65 h, t(1/2) 35.44-/+4.21 h, AUC(0-144) 2,235-/+257 microg.h.L(-1), and AUC(0-inf) 2,516-/+301 microg.h.L(-1). CONCLUSION: The system established in this study allows for highly sensitive, selective and accurate determination of plasma concentration of olanzapine, and provides valuable information for clinical trials.