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<p>The purpose of current study was to develop a sensitive, rapid, cost-effective, and precise Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of asiaticoside and chlorhexidine by using an analytical quality-by-design approach. Initially, important analytical quality-by-design prerequisites such as analytical target profile and critical analytical attributes, like area and tailing factor, were defined. The final selected chromatographic condition for the analysis of asiaticoside and chlorhexidine consists of a stationary phase {COSMOSIL 5C18-MS-II; 250&#xa0;mm × 4.6&#xa0;mm i.d, 5&#xa0;μm}, and the Mobile phase was S<sub>mix</sub> (Acetonitrile: Methanol (20:20) and orthophosphoric acid (2.5 mM; pH 3.5) in the ratio of (40:60) at a flow rate of 1.0 mL/min. The diversity of Critical Analytical Attributes with different inputs was explained using an Ishikawa fishbone diagram. The Taguchi design was selected as the first screening design to choose the critical material attributes that influence the method development. Subsequently, for more systemic optimization of the chromatographic techniques and evaluation of Critical Analytical Attributes, central composite design was employed. The developed method validation performed in accordance with ICH Q2(R2) guidelines confirmed excellent linearity (R² ≥ 0.999), accuracy (99.21–101.15%), intra- and inter-day precision (%RSD ≤ 2%), specificity, and robustness against deliberate variations. The method was successfully applied to asiaticoside-chlorhexidine-loaded nanostructured lipid carriers’ formulations, demonstrating high entrapment efficiency, asiaticoside (87%) and chlorhexidine (84%), with a sustained biphasic release profile of ~ 75% drug release over 24&#xa0;h, contrasting with the rapid release of pure drugs. This analytical quality-by-design-driven approach not only ensures scientific reliability but also regulatory compliance, offering a precise, accurate, and quality-assured analytical tool for the simultaneous estimation of asiaticoside and chlorhexidine in advanced wound-healing systems.</p> Graphical Abstract <p></p>

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AQbD enabled analytical method development and validation for simultaneous estimation of Asiaticoside (AC) and Chlorhexidine (CHX) in nanostructured lipid carriers

  • 期刊论文

  • 发表日期：

    2026年3月6日

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  • Akshay Kumar,
  • Abhishek Chauhan,
  • Devesh Kumar,
  • Arpan Kumar Tripathi,
  • Ankit Awasthi,
  • Thakur Gurjeet Singh,
  • Suresh Babu Kondaveeti,
  • Mohit Kumar

摘要

The purpose of current study was to develop a sensitive, rapid, cost-effective, and precise Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of asiaticoside and chlorhexidine by using an analytical quality-by-design approach. Initially, important analytical quality-by-design prerequisites such as analytical target profile and critical analytical attributes, like area and tailing factor, were defined. The final selected chromatographic condition for the analysis of asiaticoside and chlorhexidine consists of a stationary phase {COSMOSIL 5C18-MS-II; 250 mm × 4.6 mm i.d, 5 μm}, and the Mobile phase was Smix (Acetonitrile: Methanol (20:20) and orthophosphoric acid (2.5 mM; pH 3.5) in the ratio of (40:60) at a flow rate of 1.0 mL/min. The diversity of Critical Analytical Attributes with different inputs was explained using an Ishikawa fishbone diagram. The Taguchi design was selected as the first screening design to choose the critical material attributes that influence the method development. Subsequently, for more systemic optimization of the chromatographic techniques and evaluation of Critical Analytical Attributes, central composite design was employed. The developed method validation performed in accordance with ICH Q2(R2) guidelines confirmed excellent linearity (R² ≥ 0.999), accuracy (99.21–101.15%), intra- and inter-day precision (%RSD ≤ 2%), specificity, and robustness against deliberate variations. The method was successfully applied to asiaticoside-chlorhexidine-loaded nanostructured lipid carriers’ formulations, demonstrating high entrapment efficiency, asiaticoside (87%) and chlorhexidine (84%), with a sustained biphasic release profile of ~ 75% drug release over 24 h, contrasting with the rapid release of pure drugs. This analytical quality-by-design-driven approach not only ensures scientific reliability but also regulatory compliance, offering a precise, accurate, and quality-assured analytical tool for the simultaneous estimation of asiaticoside and chlorhexidine in advanced wound-healing systems.

Graphical Abstract