DEVELOPMENT AND VALIDATION OF A SIMPLE AND NOVEL UV SPECTROPHOTOMETRIC APPROACH FOR THE QUANTITATIVE ESTIMATION OF ELLAGIC ACID IN BULK AS PER ICH GUIDELINES

Ellagic acid, a naturally occurring polyphenolic compound is found in various fruits and vegetables and has attracted considerable attention due to its broad spectrum of biological and pharmacological properties. Several key aspects of ellagic acid, including its antioxidant activity, anti-cancer properties, anti-inflammatory effects, protective role in cardiovascular health, as well as its antibacterial and antiviral activities, were highlighted in prior research. The proposed UV method, found to be simple and novel. The developed method aligns with the concept of “green” solvents, aiming to minimize the environmental damage typically caused by solvent use in chemical production. Ethanol was chosen as the solvent Instead of all other alternatives. The absorbance of ellagic acid was measured in the UV range, and a λmax of 254 nm was identified. Recovery studies and statistical validation further supported the findings of the study. The drug follows linearity in the concentration range of 2–10µg/ml. The low values of % RSD are indicative of the accuracy and reproducibility of the method. Precision was assessed through repeatability tests. Furthermore, adherence to the rigorous guidelines outlined in ICHQ2(R2) was ensured throughout the comprehensive validation process, consolidating the method’s credibility and suitability for analytical applications.