Stability indicating RP-HPLC method for the determination of amlodipine besylate


Volume :

5

Issue :

1

Abstract :

A simple, specific, sensitive, accurate, precise, economic & reproducible RP-HPLC method was developed for the amlodipine and validated. The proposed method utilises the Agilent technologies: Agilent 1260&1290 series. Column ZORBAX C18 100 x 4.6mm with 3.5microns particle size and a software of ECZ chrome elite, 0.2µ Millipore filter paper and by using optimum mobile phase methanol: acetonitrile: Water (80:10:10) at flow rate of 1.0ml/min at 35+/- 2oc temperature. The eluent was detected at 230nm by using U.V detector. The retention time of Amlodipine besylate was found to be 1.5 min and is economically feasible. The linearity was observed at 2-50µ.g/ml. The mean recoveries were found to be 100±2%. The method was validated for system suitability, specificity, linearity, accuracy, precision, ruggedness, robustness, LOD & LOQ as per ICH guidelines. Limit of detection and Limit of quantification of the method was found to be 2.93µg/ml and 8µg/ml shows that the developed method has adequate sensitivity. (r2 > 0.99), %R.S.D of precision was found to be
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