Analytical method development and validation of amlodipine besylate by UV-visible spectroscopy

A simple, accurate, and precise UV-Visible spectrophotometric method for the quantification of Amlodipine Besylate in pharmaceutical formulations was developed and validated in accordance with ICH Q2(R1) guidelines. The method involved the preparation of standard solutions in the concentration range of 2–10 μg∕mL, with absorbance measured at the λmax of 239 nm. The method demonstrated excellent linearity with a regression coefficient (R²) of 0.9995. Recovery studies at 80%, 100%, and 120% levels showed high accuracy, with mean recoveries ranging from 99.79% to 100.33%, confirming its reliability. Precision was evaluated through intra-day and inter-day studies, yielding %RSD values of 0.84% and 0.79%, respectively, indicating excellent repeatability. The method also showed high specificity, with no interference from excipients, and sensitivity with a LOD of 0.096 μg∕mL and LOQ of 0.291 μg∕mL. Robustness testing demonstrated minimal variation with small changes in experimental conditions. The method was successfully applied to the analysis of Amlodipine Besylate tablets, yielding an assay of 99.87% of the labeled content, which is within the acceptable range. The developed method is a reliable, cost-effective tool for routine quality control in the pharmaceutical industry for the analysis of Amlodipine Besylate in both raw materials and finished formulations.