DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR EPICATECHIN ESTIMATION WITH SOLUBILITY ANALYSIS
DOI:
https://doi.org/10.22159/ajpcr.2026v19i3.55759Keywords:
Epicatechin, Ultraviolet spectrophotometry, Method validation, Solubility, Pharmaceutical analysis,, Acacia catechu, flavonoids.Abstract
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<0.05.
Results: The developed method exhibited excellent linearity over the studied concentration range (R2=0.9982), with high precision (percent relative standard deviation [%RSD]<3.1%), acceptable accuracy (recovery 98.5–106.3%), and robust performance (%RSD<2.0%). All validation parameters were statistically acceptable (p<0.05). Solubility studies revealed that methanol demonstrated significantly higher solubility for epicatechin (12.33±0.05 mg/mL) compared with other solvents (p<0.05), followed by isopropyl alcohol and chloroform. Among the oils evaluated, castor oil (4.75±0.02 mg/mL) and coconut oil (3.89±0.01 mg/mL) showed significantly greater solubilizing capacity than other oils (p<0.05).
Conclusion: The validated UV spectrophotometric method is reliable, economical, and suitable for routine quantification of epicatechin in pharmaceutical and research applications. Furthermore, the statistically significant solubility findings (p<0.05) provide valuable guidance for the rational formulation design of epicatechin-based dosage forms.
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