Optimization and validation of an analytical method for tranexamic acid in whitening creams by rp-hplc with precolumn derivatization

Abstract

Objective: An efficient and selective analytical method with precolumn derivatization using reverse-phase high-performance liquid chromatography (RP-HPLC) was developed for the analysis of tranexamic acid in whitening creams. Methods: Derivatization was performed using 1% ninhydrin solution in methanol as a derivation agent to form a colored Ruhemann’s purple product. The analytical conditions included the use of a C18 column as the stationary phase and a methanol: acetate (20 mM) buffer at pH 4 (75:25) as the mobile phase, with a flow rate of 0.8 mL/min and UV-visible detection at a wavelength of 570 nm. Results: The average retention time of the tranexamic acid derivative was 5.413 min. The results of the calibration curves were linear, with a correlation coefficient (r) of 0.9993 at a concentration ranging from 8 to 48 ng/mL. The recovery was between 99.26% and 101.77%. The limits of detection and quantification were 1.87 ng/mL and 6.25 ng/mL, respectively. Conclusion: The analytical method developed in this study met the validation requirements and included a simple and efficient derivatization method applicable for the selective analysis of tranexamic acid in whitening creams.