Design and strategy for spectrofluorimetric determination of tranexamic acid in its authentic form and pharmaceutical preparations: application to spiked human plasma

Abstract

A creative, very sensitive and noncomplicated spectrofluorimetric technique was established and further validated to determine tranexamic acid in both its authentic form and its pharmaceutical preparation dosage forms. In the introduced technique, a reaction was found between the aliphatic primary amino group of tranexamic acid and ninhydrin/phenylacetaldehyde reagents in the presence of Torell and Steinhagen buffer pH 7.0, which led to the production of a highly fluorescent product; fluorescence intensity was measured at 475 nm after excitation at 391 nm. A calibration curve was drawn with a linear range of 0.3-2 μg/ml. Limit of detection and limit of quantification values were 0.051 and 0.155 μg/ml respectively. The introduced technique was validated based on the International Council for Harmonisation guidelines and agreed for determination of tranexamic acid in its pharmaceutical formulation. Finally, this simple method was also applied for determination of tranexamic acid in spiked human plasma.

Keywords: determination; ninhydrin; phenylacetaldehyde; spectrofluorimetry; spiked human plasma; tranexamic acid.