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%.
treatment for melasma. J Res Med Sci 2014;19:753-7.
2. Perper M, Eber AE, Fayne R, Verne SH, Magno RJ, Cervantes J, et al.
Tranexamic acid in the treatment of melasma: A review of the literature.
Am J Clin Dermatol 2017;18:373-81.
3. Bala HR, Lee S, Wong C, Pandya AG, Rodrigues M. Oral tranexamic
acid for the treatment of melasma: A review. Dermatol Surg
4. Pazyar N, Yaghoobi R, Zeynalie M, Vala S. Comparison of the efficacy
of intradermal injected tranexamic acid vs hydroquinone cream in the
treatment of melasma. Clin Cosmet Investig Dermatol 2019;12:115-22.
5. Tehranchinia Z, Saghi B, Rahimi H. Evaluation of therapeutic efficacy
and safety of tranexamic acid local infiltration in combination with
topical 4% hydroquinone cream compared to topical 4% hydroquinone
cream alone in patients with melasma: A split-face study. Dermatol Res
6. Saki N, Darayesh M, Heiran A. Comparing the efficacy of topical
hydroquinone 2% versus intradermal tranexamic acid microinjections
in treating melasma: A split-face controlled trial. J Dermatolog Treat
7. Maeda K, Naganuma M. Topical Trans-4-aminomethylcyclohexane
carboxylic acid prevents ultraviolet radiationinduced pigmentation.
J Photochem Photobiol B 1998;47:136-41.
8. Shih Y, Wu KL, Sue JW, Kumar AS, Zen JM. Determination of tranexamic
acid in cosmetic products by high-performance liquid chromatography
via a simple method. J Pharm Biomed 2008;48:1446-50.
9. Martindale W, Reynolds JE. Martindale: The Extra Pharmacopoeia.
London (UK): Royal Pharmaceutical Society; 1996.
10. Azkiyah SZ, Supardi S, Andrajati R. The risks of using tranexamic acid
and Vitamin K for decreasing prothrombin time and activated partial
thromboplastin time values in intracranial hemorrhagic patients at
rumah sakit umum pusat fatmawati Jakarta. Asian J Pharm Clin Res
11. Khan AH, Khan F, Jakram TM, Khan MA. Effects of tranexamic
acid and its derivatives on the chemical and metabolic modulation of
glutathione in aqueous solution. Asian J Pharm Clin Res 2009;2:27-33.
12. Natesan S, Thanasekaran D, Krishnaswami V, Ponnusamy C. Improved
RP-HPLC method for the simultaneous estimation of tranexamic
acid and mefenamic acid in tablet dosage form. Pharm Anal Acta
13. Hadad GM, El-Gindy A, Mahmoud WM. Optimization and validation
of an HPLC-UV method for determination of tranexamic acid in a
dosage form and in human urine. Chromatographia 2007;66:311-7.
14. Khuwawar MY, Rind FM. HPLC determination of tranexamic acid in
pharmaceutical preparations and blood. Chromatographia 2001;53:709-11.
15. Nojiri S, Uehara S, Hagiwara T, Nishijima M. High Performance
Liquid Chromatographic Determination of Aspartic Acid, Taurine,
and Tranexamic Acid by Precolumn Derivatization Using Sodium
Picrylsulfonate. Vol. 46. Tokyo-toritsu Eisei Kenkyusho Kenkyu Nenpo
Annual Report; 1995. p. 58-61.
16. Ashfaq M, Aslam A, Mustafa G, Danish M, Nazar MF, Asghar MN.
Derivatization/chromophore introduction of tranexamic acid and its
hplc determination in pharmaceutical formulations. J Assoc Arab Univ
Basic Appl 2015;17:51-6.
17. Patil R, Ahmed AK, Firke S, Pawar D. RP-HPLC PDA analysis
of tranexamic acid in bulk and tablet dosage form. Anal Chem Lett
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