A NOVEL UV SPECTROPHOTOMETRIC APPROACH FOR THE DETERMINATION OF ETODOLAC: METHOD DEVELOPMENT AND ANALYTICAL VALIDATION

Jalappa Biradar*, Vijay Kumar and Roopam Devaliya

ABSTRACT

A novel UV spectrophotometric method was developed and validated for the quantitative determination of Etodolac in pharmaceutical formulations. The method was optimized using methanol as the solvent and validated following ICH guidelines. Linearity was established in the 10–60 μg/mL concentration range, with a correlation coefficient (R²) of 0.999. The accuracy was confirmed through recovery studies at 80%, 100%, and 120% levels, yielding recoveries between 99.16% and 101.00%. Precision studies, including intra-day and inter-day assessments, demonstrated excellent reproducibility with %RSD values below 2%. Sensitivity parameters were evaluated, with the limit of detection (LOD) at 0.0433 ± 0.651 μg/mL and the limit of quantification (LOQ) at 0.1312 ± 0.012 μg/mL. Robustness and ruggedness tests indicated method stability under varied conditions. The developed UV spectrophotometric method offers a simple, cost-effective, accurate, and reliable approach for routine quality control analysis of Etodolac in pharmaceutical formulations. Its high sensitivity and precision make it suitable for the detection and quantification of trace drug amounts in complex matrices.

Keywords: Etodolac Quantification, UV spectroscopy, Analytical Validation, Pharmaceutical Analysis.