DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR EPICATECHIN ESTIMATION WITH SOLUBILITY ANALYSIS

Objectives: This study aimed to develop and validate an ultraviolet (UV) spectrophotometric method for the accurate and reproducible quantification of epicatechin in bulk form. In addition, the solubility profile of epicatechin in various pharmaceutical solvents and oils was systematically investigated to support formulation development. Methods: Method development was carried out using pure epicatechin with methanol as the solvent. The method was validated according to international council for harmonization guidelines by evaluating linearity, precision (intra-day and inter-day), accuracy, limit of detection, limit of quantification, and robustness. Solubility studies were performed by equilibrating excess epicatechin with selected solvents (methanol, isopropyl alcohol, chloroform, ethyl acetate, water, and 1-butanol) and oils (castor oil, coconut oil, eucalyptus oil, olive oil, and clove oil), followed by quantitative analysis using UV spectrophotometry. Statistical analysis was applied where applicable, with significance considered at p