Green analytical method development and validation for Flavokawain A using RP-HPLC in bulk and in-house tablet dosage...

Flavokawain A, a bioactive chalcone isolated from piper methysticum (kava-kava), possesses a range of therapeutic properties, including anti-inflammatory, analgesic, cardioprotective, and anticancer activities. Despite its pharmacological potential, a dedicated and validated analytical method for its quantification has not yet been reported. This study aimed to develop and validate a simple, sensitive, and eco-friendly reverse-phase high performance liquid chromatography (RP-HPLC) method for the estimation of Flavokawain A in both bulk drug and in-house tablet dosage forms. Chromatographic separation was achieved using a "Shim-pack GIST C18 column (150×4.6mm, 3μm)" with a methanol:water (85:15 v/v) mobile phase at a flow rate of 1.0mL/min. Flavokawain A was eluted at 4.8minutes, showing excellent linearity over the range of 2-12μg/mL (R²=0.9999). The method exhibited high sensitivity with LOD and LOQ values of 0.281 and 0.853μg/mL, respectively. Recovery studies showed values between 99.2% to 101.3%, with %RSD below 2%, indicating high accuracy and precision. Assay results demonstrated 100.1% content in bulk and 99.5-101.7% in tablet formulations. The method's green chemistry profile was confirmed with an analytical greenness (AGREE) metric score of 0.79. The developed RP-HPLC method is simple, accurate, precise, and environmentally sustainable, making it highly suitable for the routine quality control and research-based quantification of Flavokawain A in pharmaceutical formulations.