A Process of Sonication-Assisted Extraction and Quantification of Baicalein in Clerodendrum serratum Linn. Leaf Extract through QbD Supported Green Photometric Method

Abstract

Introduction: Herbal medication standardization necessitates simple, dependable, and ecologically friendly analytical procedures. Clerodendrum serratum Linn. is a medicinal plant high in flavonoids, with baicalein acting as a key bioactive indicator for quality assessment.

Objectives: The current study intended to develop and validate a green, QbD-supported UV photometric method for measuring baicalein in Clerodendrum serratum Linn. leaf extract after sonication-assisted extraction.

Methods: A UV-based analytical technique was devised that uses methanol and water (25:75 v/v) as solvent and detects at 275 nm. Analytical Quality by Design (AQbD) concepts were followed, including risk assessment and optimization via Central Composite Design. Sonication-assisted extraction was used to increase the recovery of baicalein from plant material. The approach was validated using ICH criteria. Forced degradation tests were carried out under various stress situations to confirm the stability-indicating capacity. The greenness of the procedure was evaluated using the AGREE and GAPI tools.

Results: The technique demonstrated excellent linearity in the range of 2-10 µg/mL (r²=0.9997), with low LOD (0.24 µg/mL) and LOQ (0.75 µg/mL), indicating great sensitivity. The precision and accuracy levels were acceptable (%RSD < 2; recovery 98-102%). Degradation investigations have proven that the approach indicates stability. The extract contained 98.60 ± 0.55% baicalein, corresponding to 1.57 ± 0.0058 mg/g of dried plant material. The AGREE score of 0.70 suggested favorable environmental compatibility.

Conclusion: The proposed method is simple, precise, eco-friendly, and suitable for routine quality control and standardization of baicalein in Clerodendrum serratum Linn. Leaf extract.