Development of the Measurment of Gliclazide in Serum by High-performance Liquid Chromatography Method and its Pharmacokinetics in Non-Insulin Dependent Diabetic Mellitus (NIDDM) Patients and NIDDM Patients with Liver Cirrhosis

Abstract

Gliclazide is a hypoglicemic drug that highly binds to plasma proteins, but it is little reported about pharmacokinetics of free gliclazide which has a hypoglicemic action. In this study, we had an aim of establishing the HPLC method to measure free gliclazide and clarifying the effect of some diseases on it. Calibration curves were linear in the range of 0.2-10μg/ml (r=0.999). The limit of determination was 0.2μg/ml (C. V. 2.8%). Binding of gliclazide was not influenced by FFA under conditions employed and was dependent on bovin serum albumin (BSA) concentrations in vitro. In clinical, area under the curve (AUC) of free gliclazide of NIDDM with liver cirrhosis (n=3) was twice that of NIDDM without complication (n=8).(2.7±0.2 vs 1.3±0.2μg·hr/ml)