Spectrophotometric Method Development and Validation for Quantitative Estimation of Amlodipine Besylate in Bulk Drug and Their Dosage Forms By Using Hydrotropic Agent

A novel, safe, accurate and sensitive spectrophotometric method was developed using 2 mol L^-1 sodium acetate solution as hydrotropic solubilizing agent for the quantitative determination of poorly water-soluble drug amlodipine besylate in tablet dosage form. There was more than 75 foldenhancement in the solubility of amlodipine besylate in 2 mol L^-1 sodium acetate solution as compared to solubility in distilled water. Amlodipine besylate shows maximum absorbance at 365 nm. Sodium acetate did not show any absorbance above 240 nm and thus no interference in the estimation of drug was seen. The sample follows the Beer’s law in the concentration range of 50 to 250 μg.mL^-1 (r^2= 0.9998) with mean recovery ranging from 97.84 to 100.16%. Proposed method is new, simple, economic, safe, rapid, accurate and reproducible. The developed method was validated according to ICH guidelines and found to be in good accordance with the prescribed values.