Abstract

Objective: Whitening cream is a cosmetic that contains ingredients that can alleviate hyperpigmentation. Tranexamic acid (TA) is one of the potentialanti-pigmentation agents that work through inhibiting plasmin. TA is used in cosmetic formulations at a concentration of 2.5% as a whitening andmoisturizing agent. To date, research on TA in both cosmetics and other pharmaceutical products using high-performance liquid chromatography(HPLC) has not been done directly (without derivatization). Therefore, this study aimed to develop a simple and rapid analytical method for TA(without derivatization) in cosmetic cream samples using reverse-phase HPLC and water as a solvent.Methods: Optimization was conducted by evaluating several parameters that affect sample extraction, as well as composition and mobile phasetypes. The optimal method must fulfill suitability and validation requirements. The optimal method should be able to detect and quantify TA in creamsamples without derivatization.Results: The optimal analysis condition used a ultraviolet detector at a wavelength of 210 nm, acetonitrile: double-distilled water: phosphoric acid(64:34:2) as the mobile phase and a flow rate of 0.8 mL/min. The retention time of the analyte occurred in the 2nd min.Conclusion: The analytical method that met the validation requirements was characterized using parameters such as accuracy, precision, linearity,selectivity, limit, of detection, and limit of quantitation. This method is applicable for analyzing TA content in samples with a concentration of 1.02%.

Highlights

  • Tranexamic acid (TA) (Fig. 1) is an antifibrinolytic agent used to treat menorrhagia

  • The analytical method that met the validation requirements was characterized using parameters such as accuracy, precision, linearity, selectivity, limit, of detection, and limit of quantitation. This method is applicable for analyzing TA content in samples with a concentration of 1.02%

  • TA does not have a high number of chromophore groups, and it is difficult to detect through UV spectroscopy

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Summary

Introduction

Tranexamic acid (TA) (Fig. 1) is an antifibrinolytic agent used to treat menorrhagia. TA has been studied for its anti-melasma potential compared with standard therapy [2]. The previous studies on the derivatization of TA used derivative agents such as 0.2% ninhydrin in methanol [12], phenyl isothiocyanate [13], 2-hydroxynaphthaldehyde in ethanol [14], sodium picryl sulfonate [15], benzenesulfonyl chloride [16], and 2,4-dinitrofluorobenzene [17]. None of these studies reported direct analysis using UV-HPLC. The method of sample preparation and HPLC analysis was optimized to increase its sensitivity and selectivity to permit TA analysis without derivatization through a simpler method

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