High-Performance Liquid Chromatographic Determination of Ethamsylate in Urine and Tablets

Abstract

A simple, selective, sensitive, accurate, and precise method was developed for determination of ethamsylate (ET) in human urine and in ET tablets using RP-HPLC. The method uses a C18 (5 pm particle size) column at ambient temperature with the mobile phase 14.7 mM potassium dihydrogen phosphate (pH 4.6)-8.15 mM tetraheptylammonium bromide in acetonitrile (50 + 50, v/v) at a flow rate of 1.0 mL/min. Quantitation was achieved with UV detection at 300 nm, based on peak area with a linear calibration curve in the concentration range of 0.1-100 microg/mL. The proposed method was applied for the determination of the urinary excretion pattern of ET as the cumulative amounts excreted have been calculated without pretreatment of urine samples. The proposed method was completely validated according to U.S. Food and Drug administration guidelines.