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Objective <p>This study aimed to develop and optimize a rapid, robust, and efficient reversed-phase HPLC (RP-HPLC) method for luteolin using a Quality by Design (QbD)-based framework.</p> Methods <p>Method development was guided by a 3² full factorial design, employing flow rate (0.5–1.5 mL/min) and injection volume (20–100 µL) as independent variables, while retention time (RT) and theoretical plates (N) were considered critical method attributes. Experimental data were modeled using ANOVA and quadratic response surface methodology. Optimization was performed using the desirability function, and the method was validated against predicted values.</p> Results <p>Both responses were best explained by quadratic models, with high adjusted and predicted R² values (Adj R² ≥ 0.93; Pred R² ≥ 0.76). Flow rate exerted a strong negative influence on RT and a quadratic effect on efficiency, while injection volume showed a minor but significant quadratic contribution. Optimal chromatographic conditions were identified as 1.0 mL/min flow rate and 20 µL injection volume, yielding a predicted RT of 9.205&#xa0;min and 21,747 theoretical plates. Experimental validation closely matched predictions (RT: 8.993&#xa0;min; <i>N</i>: 19,678), confirming model accuracy. Compared with previously published luteolin methods reporting longer run times (14–25&#xa0;min), the optimized method demonstrated superior efficiency and throughput.</p> Conclusion <p>A QbD-driven RP-HPLC method was successfully developed and optimized for luteolin, offering high reproducibility, efficiency, and rapid analysis within a regulatory-compliant design space. This robust method holds significant potential for application in pharmacokinetic studies, formulation development, and routine quality control of luteolin-containing products.</p>

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QbD-Guided RP-HPLC Method for Luteolin Featuring Full Factorial Design and Response Surface Optimization

  • 期刊论文

  • 发表日期：

    2026年3月6日

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  • Vishin Ashish Patil,
  • Ashwin J. Mali

摘要

Objective

This study aimed to develop and optimize a rapid, robust, and efficient reversed-phase HPLC (RP-HPLC) method for luteolin using a Quality by Design (QbD)-based framework.

Methods

Method development was guided by a 3² full factorial design, employing flow rate (0.5–1.5 mL/min) and injection volume (20–100 µL) as independent variables, while retention time (RT) and theoretical plates (N) were considered critical method attributes. Experimental data were modeled using ANOVA and quadratic response surface methodology. Optimization was performed using the desirability function, and the method was validated against predicted values.

Results

Both responses were best explained by quadratic models, with high adjusted and predicted R² values (Adj R² ≥ 0.93; Pred R² ≥ 0.76). Flow rate exerted a strong negative influence on RT and a quadratic effect on efficiency, while injection volume showed a minor but significant quadratic contribution. Optimal chromatographic conditions were identified as 1.0 mL/min flow rate and 20 µL injection volume, yielding a predicted RT of 9.205 min and 21,747 theoretical plates. Experimental validation closely matched predictions (RT: 8.993 min; N: 19,678), confirming model accuracy. Compared with previously published luteolin methods reporting longer run times (14–25 min), the optimized method demonstrated superior efficiency and throughput.

Conclusion

A QbD-driven RP-HPLC method was successfully developed and optimized for luteolin, offering high reproducibility, efficiency, and rapid analysis within a regulatory-compliant design space. This robust method holds significant potential for application in pharmacokinetic studies, formulation development, and routine quality control of luteolin-containing products.