Validation of UV-vis spectrophotometric method for quantification of 3,4‑Methylenedioxychalcone in bulk drug form

Abstract

Background: This study reports the method development and validation of a UV-Vis spectrophotometric method for quantifying the research compound 3,4-methylenedioxychalcone. Chalcones, a class of flavonoid derivatives, are known for their broad pharmacological potential and reliable quantification is crucial for further pharmacological investigations, purity assessment and formulation development. However, no validated UV-Vis spectrophotometric method has been reported for the estimation of 3,4-methylenedioxychalcone. Methods: The chosen solvent was ethanol due to its stable baseline and reproducible absorbance profile. The compound exhibited a sharp absorption maximum at 353 nm. Calibration curves created over the range of 2–12 µg/mL followed Beer’s law with excellent linearity (R² = 0.9974). Validation was performed in compliance with ICH Q2(R1) recommendations, covering linearity, precision, robustness, ruggedness, limit of detection (LOD) and limit of quantification (LOQ). Results: Sensitivity studies established the LOD at 1.06 µg/mL and the LOQ at 3.23 µg/mL. The developed method demonstrated excellent linearity, precision and reproducibility, with all validation parameters meeting the acceptance criteria specified in ICH guidelines. The method was found to be reliable for quantitative estimation of 3,4-methylenedioxychalcone under the experimental conditions employed. Conclusion: The developed method is precise, economical and suitable for laboratory estimation of 3,4-methylenedioxychalcone during preclinical research. Furthermore, the validated method may serve as a useful analytical tool for purity assessment, stability studies and future formulation development involving this synthetic chalcone derivative.