OPTIMIZATION AND VALIDATION OF AN ANALYTICAL METHOD FOR TRANEXAMIC ACID IN WHITENING CREAMS BY RP-HPLC WITH PRECOLUMN DERIVATIZATION

  • BAITHA PALANGGATAN MAGGADANI Department of Pharmacy, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia
  • ERNIS OKTAVIANI Department of Pharmacy, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia
  • YAHDIANA HARAHAP Department of Pharmacy, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia
  • HARMITA HARMITA Department of Pharmacy, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia

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 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.

Keywords: Derivatization, Reverse-phase high-performance liquid chromatography, Ninhydrin, Optimization, Tranexamic acid, Validation, Whitening cream

References

1. Zhou XD, Tao LJ, Li J, Wu LD. Do we really need tranexamic acid
in total hip arthroplasty? A meta-analysis of nineteen randomized
controlled trials. Arch Orthop Trauma Surg 2013;133:1017-27.
2. Dunn CJ, Goa KL. Tranexamic acid: A review of its use in surgery and
other indications. Drugs 1999;57:1005-32.
3. Reynolds JE. Martindale: The Extra Pharmacopoeia. Great Britain:
Royal Pharmaceutical Society; 1996.
4. 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 Sci 2015;17:51-56.
5. 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 2011;2:115.
6. 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;66:311-17.
7. Khuhawar MY, Rind FM. HPLC determination of tranexamic acid in
pharmaceutical preparations and blood. Chromatographia 2001;53:709-11.
8. 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. Tokyo
Toritsu Eisei Kenkyusho Kenkyu Nenpo 1995;46:58-61.
9. Patil R, Ahmed AK, Firke S, Pawar D. RP-HPLC PDA analysis
of tranexamic acid in bulk and tablet dosage form. Anal Chem Lett
2017;7:813-21.
10. Moore S, Stein WH. Photometric ninhydrin method for use in the
chromatography of amino acids. J Biol Chem 1948;176:367-88.
11. Ramminger U, Nickel U, Geide B. Enhancement of an insufficient dyeformation
in the ninhydrin reaction by a suitable post treatment process.
J Forensic Sci 2001;46:288-93.
12. Friedman M. Applications of the ninhydrin reaction for analysis of
amino acids, peptides, and proteins to agricultural and biomedical
sciences. J Agr Food Chem 2004;52:385-406.
13. Sahani S, Jain V. A novel reversed-phase high-performance liquid
chromatography method for simultaneous estimation of drotaverine
hydrochloride, ethamsylate, and tranexamic acid in tablet dosage form.
Asian J Pharm Clin Res 2018;11:121-5.
14. Ebrahimi B, Naeini FF. Topical tranexamic acid as a promising
treatment for melasma. J Res Med Sci 2014;19:753-7.
15. Kausar R, Akhtar N. Evaluation of depegmenting and antierythemic
effects of cosmetic emulgels containing raspberry fruit extract on
human cheek skin. Int J Pharm Pharm Sci 2016;9:236-8.
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MAGGADANI, B. P., OKTAVIANI, E., HARAHAP, Y., & HARMITA, H. (2020). OPTIMIZATION AND VALIDATION OF AN ANALYTICAL METHOD FOR TRANEXAMIC ACID IN WHITENING CREAMS BY RP-HPLC WITH PRECOLUMN DERIVATIZATION. International Journal of Applied Pharmaceutics, 12(1), 167-171. https://doi.org/10.22159/ijap.2020.v12s1.FF036
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