Development of a direct method of analyzing tranexamic acid levels in whitening cream using reversed phase high-performance liquid chromatography

Objective: Whitening cream is a cosmetic that contains ingredients that can alleviate hyperpigmentation. Tranexamic acid (TA) is one of the potential anti-pigmentation agents that work through inhibiting plasmin. TA is used in cosmetic formulations at a concentration of 2.5% as a whitening and moisturizing 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 phase types. The optimal method must fulfill suitability and validation requirements. The optimal method should be able to detect and quantify TA in cream samples 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%.