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Background <p>Mangiferin (MGF), known for its antioxidant and anticancer properties, is widely used in pharmaceutical formulations. Analytical Quality by Design (AQbD) is a systematic, science-driven approach that develops robust and reliable analytical methods, ensuring consistent precision and reproducibility essential for drug safety and efficacy.&#xa0;</p> Experimental <p>This study aimed to develop and validate a robust RP-HPLC method for quantifying MGF in bulk and MGF-loaded nanoliposomes using AQbD principles.&#xa0;The method optimization was performed using Box-Behnken Design (BBD) with organic phase ratio (X₁), flow rate (X₂), and column temperature (X₃) as independent variables; retention time (Y₁), tailing factor (Y₂), and theoretical plates (Y₃) were dependent variables. Seventeen experimental trials identified optimal conditions consisting of a mobile phase of 0.1% Formic acid in water and methanol (60:40% v/v), flow rate 1.0 mL/min, column temperature 35 °C, using Phenomenex Luna C18 column (5 µm, 150 mm × 4.6 mm).</p> Results and conclusion <p>MGF retention time was 3.095 min. The method demonstrated excellent linearity across 10–60 μg/mL (R²=0.9983), with LOD and LOQ of 1.066 μg/mL and 3.23 μg/mL respectively. Recovery studies from MGF loaded nanoliposomes yielded values between 95.21 to 98.85%. Forced degradation studies indicated notable degradation under alkaline and photolytic stress. While application to biological matrices (plasma and urine) produced recoveries above 95%, underscoring bioanalytical applicability. The developed RP-HPLC method applied sustainable environmental impact using AGREE (0.82),GAPI (0.5), AES (90), BAGI (77.5) and RGB (98.9%) model these results provides accurate, economical and green chemistry approach for quantifying MGF, making it a valuable tool for pharmaceutical research and quality assurance in complex formulations and drug development.</p> Graphical Abstract <p> The study integrates chromatographic optimization, QbD Implementation, and nanostructure characterization to develop a robust Analytical method Mangiferin. HPLC conditions were optimized through design plots and 3D response surfaces, ensuring efficient separation and reproducibility. The Mangiferin was encapsulated within amphiphilic nanostructures, characterized by particle size distribution and stability analysis. Validation parameters, matrix effect and Green, Blue and white analytical scoring, confirmed method sustainability and regulatory compliance. Together, this workflow highlights a comprehensive approach to Mangiferin’s analytical method development, bridging experimental optimization with green chemistry principles.</p> <p></p>

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Sustainable RP-HPLC Method Development Using AQbD Approach for Mangiferin Loaded Nanoliposomes and Biological Fluids

  • 期刊论文

  • 发表日期：

    2026年5月22日

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  • Rohan Singadi,
  • Sunil S. Jalalpure,
  • Atith Muppayyanamath,
  • Bhaskar Kurangi

摘要

Background

Mangiferin (MGF), known for its antioxidant and anticancer properties, is widely used in pharmaceutical formulations. Analytical Quality by Design (AQbD) is a systematic, science-driven approach that develops robust and reliable analytical methods, ensuring consistent precision and reproducibility essential for drug safety and efficacy. 

Experimental

This study aimed to develop and validate a robust RP-HPLC method for quantifying MGF in bulk and MGF-loaded nanoliposomes using AQbD principles. The method optimization was performed using Box-Behnken Design (BBD) with organic phase ratio (X₁), flow rate (X₂), and column temperature (X₃) as independent variables; retention time (Y₁), tailing factor (Y₂), and theoretical plates (Y₃) were dependent variables. Seventeen experimental trials identified optimal conditions consisting of a mobile phase of 0.1% Formic acid in water and methanol (60:40% v/v), flow rate 1.0 mL/min, column temperature 35 °C, using Phenomenex Luna C18 column (5 µm, 150 mm × 4.6 mm).

Results and conclusion

MGF retention time was 3.095 min. The method demonstrated excellent linearity across 10–60 μg/mL (R²=0.9983), with LOD and LOQ of 1.066 μg/mL and 3.23 μg/mL respectively. Recovery studies from MGF loaded nanoliposomes yielded values between 95.21 to 98.85%. Forced degradation studies indicated notable degradation under alkaline and photolytic stress. While application to biological matrices (plasma and urine) produced recoveries above 95%, underscoring bioanalytical applicability. The developed RP-HPLC method applied sustainable environmental impact using AGREE (0.82),GAPI (0.5), AES (90), BAGI (77.5) and RGB (98.9%) model these results provides accurate, economical and green chemistry approach for quantifying MGF, making it a valuable tool for pharmaceutical research and quality assurance in complex formulations and drug development.

Graphical Abstract

The study integrates chromatographic optimization, QbD Implementation, and nanostructure characterization to develop a robust Analytical method Mangiferin. HPLC conditions were optimized through design plots and 3D response surfaces, ensuring efficient separation and reproducibility. The Mangiferin was encapsulated within amphiphilic nanostructures, characterized by particle size distribution and stability analysis. Validation parameters, matrix effect and Green, Blue and white analytical scoring, confirmed method sustainability and regulatory compliance. Together, this workflow highlights a comprehensive approach to Mangiferin’s analytical method development, bridging experimental optimization with green chemistry principles.