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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 themobile 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 acorrelation 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 ofdetection 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 methodapplicable for the selective analysis of tranexamic acid in whitening creams.
Highlights
Tranexamic acid, or trans-4-(aminomethyl)cyclohexanecarboxylic acid (Fig. 1), is an antifibrinolytic drug that works by inhibiting the activation of plasminogen into plasmin [1]
Because tranexamic acid does not have a chromophore group, it cannot be measured with a UV–visible detector and requires a derivatization process to increase its detection sensitivity [4]
The previous studies on the derivatization of tranexamic acid reported the use of various derivative agents, such as 0.2% ninhydrin in methanol [5], phenyl isothiocyanate [6], 2-hydroxynaphthaldehyde in ethanol [7], sodium picryl sulfonate [8], benzene sulfonyl chloride [4], and 2,4-dinitrofluorobenzene [9]
Summary
Tranexamic acid, or trans-4-(aminomethyl)cyclohexanecarboxylic acid (Fig. 1), is an antifibrinolytic drug that works by inhibiting the activation of plasminogen into plasmin [1]. Tranexamic acid is used as an ingredient in whitening creams at a maximum concentration range of 1.5–2% [2]. The excessive use of tranexamic acid on the skin can cause local toxicity, including irritation and allergies [3]. The presence of tranexamic acid in whitening cream preparations should be considered so that the concentration does not exceed the specified limit. The previous studies on the derivatization of tranexamic acid reported the use of various derivative agents, such as 0.2% ninhydrin in methanol [5], phenyl isothiocyanate [6], 2-hydroxynaphthaldehyde in ethanol [7], sodium picryl sulfonate [8], benzene sulfonyl chloride [4], and 2,4-dinitrofluorobenzene [9]
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