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<p>A green, statistically optimized high-performance thin-layer chromatography (HPTLC) method was developed and validated for the quantification of β-sitosterol in <i>Ailanthus excelsa</i> Roxb. extract-loaded phytosomes and biological matrices. The method optimization was guided by a Box–Behnken design (BBD), evaluating the effects of formic acid content, saturation time, and migration distance. Response surface methodology (RSM) identified optimal chromatographic conditions with a desirability value of 1.0. The finalized method exhibited excellent linearity over the range of 100–500&#xa0;ng/band (<i>R</i><sup>2</sup> = 0.9994), with limit of detection and limit of quantification determined as 31.6 and 94.5&#xa0;ng/band, respectively. The method demonstrated acceptable intra- and inter-day precision (%RSD &lt; 2%). Phytosomes were fabricated using a thin-film hydration technique, yielding vesicles with a mean particle size of 164.9 ± 0.86&#xa0;nm, polydispersity index of 0.286, and zeta potential of −24.63 ± 0.036&#xa0;mV, indicating colloidal stability. The encapsulation efficiency of β-sitosterol was 35.62 ± 0.61%. Analytical recovery from phytosomal formulations ranged between 61.18 and 62.58%, while recovery from plasma and urine samples exceeded 98%, affirming method accuracy and reliability for bioanalytical applications. β-Sitosterol stability was maintained under various stress conditions including bench-top, freeze–thaw, autosampler, wet and dry extract, and short and long-term storage. Environmental impact assessment using ComplexGAPI, AGREE (score: 0.71), AGREEprep (0.67), Analytical Eco-Scale (75), and BAGI (72.5) demonstrated the method’s alignment with green and white analytical chemistry principles. This validated that the HPTLC method provides a sustainable, robust, and precise analytical platform for routine quantification of β-sitosterol in plant-based nanoformulations, supporting applications in pharmaceutical development and pharmacokinetic studies.</p>

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Development and validation of a green high-performance thin-layer chromatography method for β-sitosterol: application to Ailanthus excelsa phytosomes and bioanalytical samples

  • 期刊论文

  • 发表日期：

    2025年10月23日

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  • Sachin Gudasi,
  • M. B. Patil,
  • Rahul Koli,
  • Shankar Gharge

摘要

A green, statistically optimized high-performance thin-layer chromatography (HPTLC) method was developed and validated for the quantification of β-sitosterol in Ailanthus excelsa Roxb. extract-loaded phytosomes and biological matrices. The method optimization was guided by a Box–Behnken design (BBD), evaluating the effects of formic acid content, saturation time, and migration distance. Response surface methodology (RSM) identified optimal chromatographic conditions with a desirability value of 1.0. The finalized method exhibited excellent linearity over the range of 100–500 ng/band (R2 = 0.9994), with limit of detection and limit of quantification determined as 31.6 and 94.5 ng/band, respectively. The method demonstrated acceptable intra- and inter-day precision (%RSD < 2%). Phytosomes were fabricated using a thin-film hydration technique, yielding vesicles with a mean particle size of 164.9 ± 0.86 nm, polydispersity index of 0.286, and zeta potential of −24.63 ± 0.036 mV, indicating colloidal stability. The encapsulation efficiency of β-sitosterol was 35.62 ± 0.61%. Analytical recovery from phytosomal formulations ranged between 61.18 and 62.58%, while recovery from plasma and urine samples exceeded 98%, affirming method accuracy and reliability for bioanalytical applications. β-Sitosterol stability was maintained under various stress conditions including bench-top, freeze–thaw, autosampler, wet and dry extract, and short and long-term storage. Environmental impact assessment using ComplexGAPI, AGREE (score: 0.71), AGREEprep (0.67), Analytical Eco-Scale (75), and BAGI (72.5) demonstrated the method’s alignment with green and white analytical chemistry principles. This validated that the HPTLC method provides a sustainable, robust, and precise analytical platform for routine quantification of β-sitosterol in plant-based nanoformulations, supporting applications in pharmaceutical development and pharmacokinetic studies.