Analytical Method development and validation for ranolazine in tablet dosage form by UV-Spectrophotometry

Abstract

A simple, rapid, accurate, and cost-effective UV spectrophotometric method was developed and validated for the quantitative estimation of Ranolazine in pharmaceutical tablet formulations. Ranolazine, an anti-anginal drug used in the treatment of chronic stable angina, was analyzed using a hydrotropic solubilizing agent (0.2 M urea) as the solvent. The absorption maximum (λmax) of Ranolazine was found to be 271 nm. The method showed good linearity in the concentration range of 40–120 µg/mL with a correlation coefficient (R²) of 0.9986. The developed method was validated according to ICH guidelines for parameters such as precision, accuracy, linearity, limit of detection (LOD), limit of quantification (LOQ), robustness, and ruggedness. The LOD and LOQ values were found to be 3.35 µg/mL and 10.16 µg/mL respectively. The percentage recovery ranged between 100–102%, confirming the accuracy of the method. The developed method was successfully applied for the assay of Ranolazine tablets with satisfactory results. The results demonstrated that the proposed method is reliable and suitable for routine quality control analysis of Ranolazine in pharmaceutical formulations.