Simple and Sensitive HPLC Method for Determination of Gemfibrozil in Human Plasma with Fluorescence Detection

Abstract

A sensitive and simple high performance liquid chromatography (HPLC) with fluorescence detection was developed for the determination of gemfibrozil in a small plasma sample. The plasma sample was analyzed by a deproteination method that had very simple pretreatment steps. Ibuprofen was used as an internal standard. The analysis of gemfibrozil in the plasma sample was carried out using a reverse phase C₁₈ column with fluorescence detection (a maximum excitation at 242 nm and a minimum emission at 300 nm). A mixture of acetonitrile–0.4% phosphoric acid solution (53∶47, v/v) was used as a mobile phase. The detection limit of this method was 10 ng/mL using only 100 µL of plasma sample. The standard curve was an excellent linear fit over a range of 0.05–15 µg/mL of gemfibrozil in human plasma (r²=1). The inter‐ and intra‐day precision (coefficient of variation, CV%) did not exceed 15%. This simple, sensitive, and rapid method was successfully applied for the pharmacokinetic study following a single oral administration of 300 mg gemfibrozil.

Keywords:

• Gemfibrozil
• HPLC
• Fluorescence detection
• Pharmacokinetics

Acknowledgment

This work was supported by the Korea Food and Drug Administration Grant (KFDA‐04142‐EQI‐405).