Determination of Rebamipide in Human Plasma by HPLC

Abstract

A simple determination method of rebamipide in human plasma by using high performance liquid chromatography (HPLC) was developed. The method involves a single liquid–liquid extraction and reversed‐phase chromatography with fluorometric detection (excitation, 320 nm; emission, 380 nm). Analytes were extracted from plasma samples that contain an internal standard (ofloxacin) into ethylacetate with a high yield after adjustment to pH 2–3. Separation was accomplished at 60°C on a reversed‐phase column using a mobile phase of acetonitrile–water–acetic acid (30:70:5, v/v, pH 2.4), at a flow‐rate of 1.0 mL/min. The linear range of the assay was 2–500 ng/mL of the drug in plasma and the limit of quantitation was 2.0 ng/mL. The intra‐ and inter‐day relative standard deviation (RSD) were less than 10% and the accuracy of the assay was in the range of 97–104%. Analysis of the drug in human plasma indicates that the procedure can be carried out conveniently and quickly and, therefore, is suitable for obtaining pharmacokinetic profiles in human subjects after oral administration of different types of the drug.