Quantification of Arbutin and its degradation products, hydroquinone and p-Benzoquinone, in hyperpigmentation topical formulation: Effect of extraction procedure and interference assessment.

Autor: Khadivi Y; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Pharmaceutics, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran., Saeedpour M; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran., Arjmandmazidi S; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran., Nemati M; Food and Drug Safety Research Center, Tabriz University of Medical Sciences, Tabriz, Iran., Monajjemzadeh F; Department of Pharmaceutical and Food Control, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: monajjemzadehf@yahoo.com.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Aug 15; Vol. 246, pp. 116223. Date of Electronic Publication: 2024 May 15.
DOI: 10.1016/j.jpba.2024.116223
Abstrakt: The utilization of Hydroquinone (HQ) in over-the-counter skincare items is subject to restrictions. Consequently, Arbutin (AR) serves as a reliable alternative for addressing hyperpigmentation in non-prescription topical formulations. Nevertheless, AR undergoes decomposition into HQ and p-Benzoquinone (BZ) when exposed to temperature stress, ultraviolet light, or dilution in an acidic environment, all of which can induce skin toxicity. The intention of this paper is to investigate the effect of extraction procedure on the conversion of AR to HQ and or BZ and to evaluate kinetics of AR hydrolysis to HQ. Meanwhile this study aims to evaluate AR and BZ interference with the United States Pharmacopoeia (USP) identification and assessment method for HQ Hydrolytic stress during extraction conditions underwent optimization through systematic screening tests. Subsequent assessment of the residual drug and its degradation products were achieved by HPLC method. The resulting data were meticulously fitted to various kinetic models. To analyze the potential interference of AR in HQ measurement using USP method, the standard concentrations of AR and HQ were analyzed through UV-VIS spectrophotometry. For enhanced certainty, a validated HPLC method analysis was also conducted. Notably, the acid hydrolysis of AR exhibited independence from its initial concentration. So, the hydrolytic degradation of AR exhibited a Zero-order kinetic profile. Furthermore, the proven interference of AR in the UV-VIS spectrophotometry method was identified within the context of the USP method. This study successfully utilized an adopted HPLC method for the concurrent quantification of AR, HQ, and BZ. The potential interference of AR in the UV-VIS spectrophotometric assay for HQ may lead to false results especially for regulatory purposes.
Competing Interests: Declaration of Competing Interest All authors certify that they have no affiliation or involvement with any organization or entity with any financial or non-financial interest in the topic or material discussed in this article and have no competing interests, financial or non-financial, related to the publication of this article other than their affiliation declared in this project.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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