OPTIMIZATION AND VALIDATION OF AN ANALYTICAL METHOD FOR TRANEXAMIC ACID IN WHITENING CREAMS BY RP-HPLC WITH PRECOLUMN DERIVATIZATION
Keywords:Derivatization, Reverse-phase high-performance liquid chromatography, Ninhydrin, Optimization, Tranexamic acid, Validation, Whitening cream
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 μg/mL. The recovery was between 99.26% and 101.77%. The limits of
detection and quantification were 1.87 μg/mL and 6.25 μg/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.
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