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<p>This study aimed to establish and validate a thin-layer chromatography (TLC)‒densitometric method that aligns with green analytical chemistry (GAC) and white analytical chemistry (WAC) principles for the concurrent determination of benzydamine hydrochloride (BZ), cetalkonium chloride (CTK), and benzocaine (BC). The drugs under study were separated on silica gel as the stationary phase, using butanol–acetic acid–water (6:2:2, <i>V/V</i>) as the developing system. The bands were scanned at 210.0&#xa0;nm for CTK and 300.0&#xa0;nm for BZ and BC, with retardation factor (<i>R</i><sub>F</sub>) values of 0.53, 0.61, and 0.79 for BZ, CTK, and BC, respectively. During the development of the suggested method, the evaluation tools: Analytical Eco-Scale (AES), Green Analytical Procedure Index (GAPI), Analytical Greenness Metric Approach (AGREE), and the RGB12 (red–green–blue) color model were used to ensure that the standards of GAC and WAC had been applied, and to evaluate the environmental and operational sustainability of the proposed method. The applied method succeeded in determining the aforementioned drugs in their pure forms and in oromucosal spray after validation of the method in accordance with the International Council for Harmonisation (ICH) recommendations. The greenness and whiteness assessments indicated that the proposed method demonstrated noticeable sustainability characteristics when compared with the reported and manufacturer’s methods, thus recommending its potential application in quality control laboratories.</p>

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Greenness and whiteness assessment of a thin-layer chromatography‒densitometric method for the determination of three components in oromucosal spray

  • 期刊论文

  • 发表日期：

    2025年6月18日

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  • Maryam A. Bakr,
  • Samah S. Abbas,
  • Maha A. Hegazy,
  • Amr M. Badawey,
  • Sally S. El-Mosallamy

摘要

This study aimed to establish and validate a thin-layer chromatography (TLC)‒densitometric method that aligns with green analytical chemistry (GAC) and white analytical chemistry (WAC) principles for the concurrent determination of benzydamine hydrochloride (BZ), cetalkonium chloride (CTK), and benzocaine (BC). The drugs under study were separated on silica gel as the stationary phase, using butanol–acetic acid–water (6:2:2, V/V) as the developing system. The bands were scanned at 210.0 nm for CTK and 300.0 nm for BZ and BC, with retardation factor (RF) values of 0.53, 0.61, and 0.79 for BZ, CTK, and BC, respectively. During the development of the suggested method, the evaluation tools: Analytical Eco-Scale (AES), Green Analytical Procedure Index (GAPI), Analytical Greenness Metric Approach (AGREE), and the RGB12 (red–green–blue) color model were used to ensure that the standards of GAC and WAC had been applied, and to evaluate the environmental and operational sustainability of the proposed method. The applied method succeeded in determining the aforementioned drugs in their pure forms and in oromucosal spray after validation of the method in accordance with the International Council for Harmonisation (ICH) recommendations. The greenness and whiteness assessments indicated that the proposed method demonstrated noticeable sustainability characteristics when compared with the reported and manufacturer’s methods, thus recommending its potential application in quality control laboratories.