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

Abstract

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 fold
enhancement 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
(r2
= 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.