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<p>Green analytical chemistry principles focus on fabricating analytical procedures that are more environmentally friendly and safer for humans. The present study focuses on the application of a novel strategy with green chemistry principles to develop a green and robust stability-indicating thin-layer chromatography (TLC) method for the simultaneous quantification of telmisartan and azelnidipine in tablets. Merck TLC aluminum plates precoated with silica gel 60F<sub>254</sub> was used as the stationary phase. The optimized conditions generated compact well-resolved bands (<i>R</i><sub>F</sub> values for telmisartan of 0.12 ± 0.02 and for azelnidipine of 0.29 ± 0.02). The developed method was validated as per the International Council for Harmonisation (ICH) Q2(R1) guideline. The calibration curves were found to be linear over a concentration range of 1‒6&#xa0;μg/band and 0.1‒0.6&#xa0;μg/band for telmisartan and azelnidipine, respectively. The greenness of the developed method was assessed by using greenness tools, viz. Analytical Greenness Metric Tool (AGREE), Greenness Analytical Procedure Index (Complex GAPI), Blue Applicability Grade Index (BAGI), and Analytical Eco-Scale. The stability-indicating capability of the developed method was investigated by performing stress studies. The binary combination of drug substances was subjected to different stress conditions, viz. acid, base, neutral, oxidation, and photolysis, as per the ICH guideline Q1A(R2). The proposed ecofriendly, stability-indicating TLC method could be applied for routine quality control of the studied drugs in single or coformulated dosage forms.</p>

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Development of an ecofriendly novel stability-indicating thin-layer chromatography‒densitometry method for the simultaneous determination of telmisartan and azelnidipine

  • 期刊论文

  • 发表日期：

    2025年6月1日

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  • Susheel John Varghese,
  • Merina Preethi J.,
  • Siva S.

摘要

Green analytical chemistry principles focus on fabricating analytical procedures that are more environmentally friendly and safer for humans. The present study focuses on the application of a novel strategy with green chemistry principles to develop a green and robust stability-indicating thin-layer chromatography (TLC) method for the simultaneous quantification of telmisartan and azelnidipine in tablets. Merck TLC aluminum plates precoated with silica gel 60F254 was used as the stationary phase. The optimized conditions generated compact well-resolved bands (RF values for telmisartan of 0.12 ± 0.02 and for azelnidipine of 0.29 ± 0.02). The developed method was validated as per the International Council for Harmonisation (ICH) Q2(R1) guideline. The calibration curves were found to be linear over a concentration range of 1‒6 μg/band and 0.1‒0.6 μg/band for telmisartan and azelnidipine, respectively. The greenness of the developed method was assessed by using greenness tools, viz. Analytical Greenness Metric Tool (AGREE), Greenness Analytical Procedure Index (Complex GAPI), Blue Applicability Grade Index (BAGI), and Analytical Eco-Scale. The stability-indicating capability of the developed method was investigated by performing stress studies. The binary combination of drug substances was subjected to different stress conditions, viz. acid, base, neutral, oxidation, and photolysis, as per the ICH guideline Q1A(R2). The proposed ecofriendly, stability-indicating TLC method could be applied for routine quality control of the studied drugs in single or coformulated dosage forms.