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AQbD-Driven Green RP-HPLC Method Development and Validation for Simultaneous Quantification of Apremilast and
Amit Sharma1,2, Preeti Patel3, Raj Kumar Narang1,2
1Department of Pharmaceutical Sciences, I.K. Gujral Punjab Technical University, Kapurthala, Punjab, India.
Objective:
To develop and validate a green RP-HPLC method, guided by Analytical Quality by Design (AQbD), for the simultaneous quantification of apremilast and quercetin in nanostructured lipid carriers.
Significance:
Accurate simultaneous estimation of apremilast and quercetin in lipid-based nanoformulations remains limited. An AQbD-guided method with a focus on environmental sustainability offers improved robustness, reproducibility and suitability for formulation development and quality control.
Methods:
Chromatographic conditions were optimized using an AQbD framework based on a Box-Behnken Design. The RP-HPLC method was validated according to ICH guidelines for specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. The validated method was applied to determine entrapment efficiency, drug loading, and in vitro drug release from nanostructured lipid carriers. Method greenness was evaluated using AGREE, BAGI and ComplexGAPI assessment tools.
Results:
Quercetin and apremilast were detected at retention times of approximately 8.32 and 10.95 min, respectively, with satisfactory chromatographic resolution. The method demonstrated excellent linearity within the concentration range of 10-50 µg/mL, with R2 values of 0.9992 for quercetin and 0.9999 for apremilast. Precision was high with %RSD values below 1%. The optimized nanostructured lipid carriers showed entrapment efficiencies of 69.87 ± 2.41% for quercetin and 60.12 ± 2.85% for apremilast, along with sustained drug release over 24 h. Greenness assessment indicated good adherence to green analytical chemistry principles.
Conclusions:
The AQbD-driven green RP-HPLC method proved sensitive, robust and validated. It is suitable for the simultaneous quantification of apremilast and quercetin in nanostructured lipid carriers and related pharmaceutical applications.
