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Abstract

Stability Indicating Assay Method For Amlodipine Tablets

Author(s): Koustubhmani Kamat, S. C Chaturvedi

A novel stability indicating HPLC has been developed for estimation of amlodipine in tablet formulation. The method was validated using specificity, stability in analytical solution, precision, accuracy and system suitability as parameters. The mobile phase consists of 0.05 M ortho-phosphoric acid buffer, methanol and acetonitrile in the ratio of 50:35:15 and the results show that the method is reproducible and accurate. Degradation of amlodipine was performed in various conditions and the resulting solution was analyzed on HPLC using ODS column (150x4.6mm) with a detection maxima of 361 nm. The method gave a good separation between drug and degradation peaks. Recovery studies gave results between 99.7 to 100.7 % for 5 mg tablets.