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

Eurasian Journal of Analytical Chemistry

Deepak Kumar Jain¹  Sharad P. Pandey¹  Nilesh kumar Jain¹  Ruchi Jain¹  Arti Jain¹ 

关键词: Rupatadine;    Montelukast;    HPLC;    Validation ;   

DOI  :  10.12973/ejac.2010.00098a

学科分类：分析化学

来源: Eurasian Journal of Analytical Chemistry

【 摘 要 】

A novel, safe, accurate and sensitive spectrophotometric method was developed using 2 M 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 M sodium acetate solution as compared to solubility in distilled water. Amlodipine besylate shows maximum absorbance at 365nm. 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.

【 授权许可】

Unknown