Derivatization of tranexamic acid for its rapid spectrofluorimetric determination in pure form and pharmaceutical formulations: Application in human plasma.

Abstract

An ingenious approach for determination of tranexamic acid spectrofluorimetrically has been developed. This experiment is very simple, sensitive and selective method for determination of tranexamic acid in pure form, pharmaceutical dosage forms and in spiked human plasma. All optimal conditions needed in our proposed experiment have been determined and validated precisely. This developed method based on the reaction between the primary amino group found in the chemical structure of tranexamic acid with the fluorescamine reagent in presence of borate buffer (pH 8.3) that result in the formation of fluorescence product measured at 473.5nm after excitation at 392nm. We notice that the linearity of the resulted calibration curve found to be (0.1-0.9μg/mL) with LOD and LOQ results were 0.0237 and 0.0719 respectively. The validation of the developed method is according to the international council for Harmonization (ICH) guidelines indicating good accuracy and precision. Finally, the developed method has been applied for in vitro study of tranexamic acid by making spiked human plasma with a mean percentage recovery 99.430±0.623 as well as in its pharmaceutical dosage forms tablets and ampoules.