Spectrofluorimetric analysis of ticagrelor in pharmaceutical formulations and spiked human plasma using 1-dimethylaminonaphthalene-5-sulphonyl chloride reagent

Abstract

A sensitive method is presented for the determination of the ticagrelor (TCG) in human plasma andpharmaceutical preparations using 5-(dimethylamino)naphthalene-1-sulfonyl chloride (dansyl chloride). Ticagrelorcontains a secondary amino group which reacts with dansyl chloride in the presence of 0.5 M sodium bicarbonate (pH10) to yield a highly fluorescent derivative that is measured at 445 nm after excitation at 340 nm. Different experimentalparameters affecting the fluorescence intensities were carefully studied and optimized. The proposed method was alsovalidated according to ICH guidelines. The fluorescence concentration plot was rectilinear over the range of 20.0–200.0 ng mL−1, with a coefficient of determination of 0.9999 with a limit of detection (LOD) of 0.14 ng mL−1 and the limitof quantitation (LOQ) of 0.46 ng mL−1. The proposed method was applied successfully to the analysis of TCG in spikedhuman plasma and pharmaceutical dosage forms with good accuracy and precision.