Open AccessOPTIMIZATION AND VALIDATION OF AN ANALYTICAL METHOD FOR TRANEXAMIC ACID IN WHITENING CREAMS BY RP-HPLC WITH PRECOLUMN DERIVATIZATION
Author(s) -
Baitha Palanggatan Maggadani,
Ernis Oktaviani,
Yahdiana Harahap,
Harmita Harmita
Publication year - 2020
Publication title -
international journal of applied pharmaceutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.238
H-Index - 15
ISSN - 0975-7058
DOI - 10.22159/ijap.2020.v12s1.ff036
Subject(s) - chromatography , derivatization , chemistry , ninhydrin , high performance liquid chromatography , tranexamic acid , calibration curve , methanol , detection limit , amino acid , organic chemistry , medicine , biochemistry , blood loss , surgery
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.