Reliable Quantification of Rebamipide: Validated UV-Spectrophotometry Approach for Bulk and Pharmaceutical Formulations

A novel ultraviolet (UV) method, distinguished by its rapidity, sensitivity, simplicity, and cost-effectiveness, was prepared for the quantification of Rebamipide in both scaleup and pharmaceutical formulations. The absorbance of Rebamipide was measured relatively in ethanol at a new wavelength (λmax 325). The method demonstrated a linearity range spanning from 5 to 60 μg/ml, with a regression equation represented as relative absorbance 0.016x concentration in μg/ml + 0.1621, and a regression coefficient of 0.998. Validation procedures were conducted per International Council for Harmonisation (ICH) and United States Pharmacopeia (USP) specifications, affirming the method's accuracy, precision, and reproducibility (relative standard deviation <2.0%). This criterion is effective for the estimation of Rebamipide across various dosage forms, yielding results in alignment with label claims. Its validation provides a prompt, cost-effective, and accurate approach to assess Rebamipide potency and consistency in pharmaceutical products, thereby enhancing healthcare standards and ensuring patient safety.