Scholarlink

<p>Green analytical chemistry has significantly contributed to the development of environmentally benign analytical techniques by integrating sustainability principles directly into method design. In the proposed research, a sensitive, selective, and robust thin-layer chromatography (TLC) method was developed and validated for amlodipine besylate, telmisartan, and indapamide in their ternary synthetic mixture using an analytical quality by design approach. The chromatography method was enabled by aluminium-backed TLC silica gel 60 F<sub>254</sub> plates as stationary phase using toluene‒isopropanol‒methanol‒triethylamine (6:1:1.3:0.2, <i>V/V</i>) as the optimized mobile phase, and the separated bands were quantified by scanning at a detection wavelength of 255&#xa0;nm. The critical method parameters were initially identified, and the Box‒Behnken design was employed to study the effect on the selected critical analytical attributes and retention factor (<i>R</i><sub>F</sub>). For the calibration plots, the results of the linear regression analysis revealed <i>R</i><sup>2</sup> of greater than 0.99 within the concentration range of 500‒2500&#xa0;ng/band for amlodipine besylate, 100‒500&#xa0;ng/band for telmisartan, and 400‒2000&#xa0;ng/band for indapamide. The three drugs were properly resolved at <i>R</i><sub>F</sub> 0.36, 0.53, and 0.72 for amlodipine besylate, telmisartan, and indapamide, respectively, using these chromatographic conditions. A control strategy was devised for critical parameters in the design space for reliable method performance. The method was validated as per the International Council for Harmonization (ICH) Q2(R2) guidelines. The method’s greenness was assessed using complex Green Analytical Procedure Index (GAPI) and Analytical GREEnness Metric Approach and Software (AGREE) metrics.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Analytical quality by design-based optimization of ecofriendly thin‑layer chromatography‒densitometry method for quantification of antihypertensive combination using complex GAPI and AGREE tool

  • 期刊论文

  • 发表日期：

    2025年5月1日

查看全文
  • Hemangini Patel,
  • Kalpana Patel,
  • Rajnikant Mardia,
  • Tejal Soni,
  • Bhanu Suhagia

摘要

Green analytical chemistry has significantly contributed to the development of environmentally benign analytical techniques by integrating sustainability principles directly into method design. In the proposed research, a sensitive, selective, and robust thin-layer chromatography (TLC) method was developed and validated for amlodipine besylate, telmisartan, and indapamide in their ternary synthetic mixture using an analytical quality by design approach. The chromatography method was enabled by aluminium-backed TLC silica gel 60 F254 plates as stationary phase using toluene‒isopropanol‒methanol‒triethylamine (6:1:1.3:0.2, V/V) as the optimized mobile phase, and the separated bands were quantified by scanning at a detection wavelength of 255 nm. The critical method parameters were initially identified, and the Box‒Behnken design was employed to study the effect on the selected critical analytical attributes and retention factor (RF). For the calibration plots, the results of the linear regression analysis revealed R2 of greater than 0.99 within the concentration range of 500‒2500 ng/band for amlodipine besylate, 100‒500 ng/band for telmisartan, and 400‒2000 ng/band for indapamide. The three drugs were properly resolved at RF 0.36, 0.53, and 0.72 for amlodipine besylate, telmisartan, and indapamide, respectively, using these chromatographic conditions. A control strategy was devised for critical parameters in the design space for reliable method performance. The method was validated as per the International Council for Harmonization (ICH) Q2(R2) guidelines. The method’s greenness was assessed using complex Green Analytical Procedure Index (GAPI) and Analytical GREEnness Metric Approach and Software (AGREE) metrics.