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Purpose <p>To develop a stable, reliable, and environmentally sustainable RP-HPLC method for the quantification of paeonol in bovine serum albumin (BSA) nanoparticles using an Analytical Quality by Design (AQbD) approach integrated with green analytical chemistry principles.</p> Methods <p>The method was developed based on a predefined Analytical Target Profile, followed by risk assessment using Ishikawa analysis and Failure Modes and Effects Analysis to identify critical method parameters (CMPs). Taguchi screening and Box–Behnken design were applied to optimize key variables. Chromatographic separation was achieved using 0.1% formic acid in water and methanol (30:70, v/v) at a flow rate of 1.0 mL min⁻¹, with detection at 274&#xa0;nm and column temperature maintained at 30&#xa0;°C. The method was validated according to ICH Q2(R1)/Q2(R2) guidelines. Stability-indicating capability was evaluated through forced degradation studies, and greenness was assessed using AGREE, AGREEprep, ComplexGAPI, Eco-Scale, and BAGI tools.</p> Results <p>The method showed excellent linearity (2–12&#xa0;µg mL⁻¹, R² &gt; 0.999), high precision (%RSD &lt; 2%), and accuracy (98–102%). Sensitivity was demonstrated with LOD and LOQ values of 0.452&#xa0;µg mL⁻¹ and 1.495&#xa0;µg mL⁻¹, respectively. Forced degradation confirmed the stability-indicating nature of the method. Application to paeonol-loaded BSA nanoparticles (166.5&#xa0;nm, PDI 0.129, zeta potential − 29.5 mV, encapsulation efficiency 86.5%) showed recoveries between 97.1% and 98.1%. Greenness assessment confirmed the environmental sustainability of the method.</p> Conclusion <p>The developed AQbD-based green RP-HPLC method is reliable, sensitive, and environmentally sustainable, making it suitable for routine analysis and quality control of paeonol nanoformulations.</p>

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Analytical Quality by Design-Guided Green RP-HPLC Method for Stability-Indicating Quantification of Paeonol in Bovine Serum Albumin Nanoparticles

  • 期刊论文

  • 发表日期：

    2026年6月24日

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  • Umesh Suresh Biradar,
  • V. S. Mannur,
  • Vishal I. Wannur,
  • Rahul Koli

摘要

Purpose

To develop a stable, reliable, and environmentally sustainable RP-HPLC method for the quantification of paeonol in bovine serum albumin (BSA) nanoparticles using an Analytical Quality by Design (AQbD) approach integrated with green analytical chemistry principles.

Methods

The method was developed based on a predefined Analytical Target Profile, followed by risk assessment using Ishikawa analysis and Failure Modes and Effects Analysis to identify critical method parameters (CMPs). Taguchi screening and Box–Behnken design were applied to optimize key variables. Chromatographic separation was achieved using 0.1% formic acid in water and methanol (30:70, v/v) at a flow rate of 1.0 mL min⁻¹, with detection at 274 nm and column temperature maintained at 30 °C. The method was validated according to ICH Q2(R1)/Q2(R2) guidelines. Stability-indicating capability was evaluated through forced degradation studies, and greenness was assessed using AGREE, AGREEprep, ComplexGAPI, Eco-Scale, and BAGI tools.

Results

The method showed excellent linearity (2–12 µg mL⁻¹, R² > 0.999), high precision (%RSD < 2%), and accuracy (98–102%). Sensitivity was demonstrated with LOD and LOQ values of 0.452 µg mL⁻¹ and 1.495 µg mL⁻¹, respectively. Forced degradation confirmed the stability-indicating nature of the method. Application to paeonol-loaded BSA nanoparticles (166.5 nm, PDI 0.129, zeta potential − 29.5 mV, encapsulation efficiency 86.5%) showed recoveries between 97.1% and 98.1%. Greenness assessment confirmed the environmental sustainability of the method.

Conclusion

The developed AQbD-based green RP-HPLC method is reliable, sensitive, and environmentally sustainable, making it suitable for routine analysis and quality control of paeonol nanoformulations.