Assay of Aminocaproic Acid in Dosage Forms by Reversed Phase High Performance Liquid Chromatography with Dansylation

Abstract

A HPLC method with precolumn derivatization is described for the assay of aminocaproic acid in solid and liquid dosage forms. Tablets are extracted into or liquid dosage forms are diluted with water, and the aqueous extracts are reacted with dansyl chloride in an alkaline solution containing the internal standard tranexamic acid. After removal of the excess of dansyl chloride with monoethanolamine, the mixture of dansyl derivatives is analyzed on an Econosphere C₁₈ reversed phase column, with a methanol-water-acetic acid-triethylamine (60:38: 1.5:0.5) mobile phase delivered at the rate of 1.5 mL/ min, and a detection wavelength of 335 nm. Detector responses were rectilinearly related to on column concentrations of aminocaproic acid between 0.05 and 2 μg. The proposed method was found suitable for the analysis of commercial tablets, injections and syrups, and of samples from tablet dissolution tests. Assay results by this method were in close agreement with those obtained using assay methods of the USP XXII