Analytical method development and validation of Amlodipine besylate in tablet dosage form

Abstract

The  accurate and precise HPLC analytical method validated for the determination of Amlodipine besylate  in pharmaceutical dosage form.The chromatographic separation is carried out on shimadzu HPLC system (LC-2010 CHT)  with  UV Vissible  detector and C18(150mm x3.9 mm) 5 μm Column. The Mobile phase consists of Acetonitrile: Methanol: PH 3.0 Buffer (15 V: 35 V: 50 V) , at the flow rate  of  1.0 ml/min and elutes were monitoring  at 237 nm. The observed retention time for Amlodipine besylate was 10.8 min. The % RSD for system precision was 0.41 % and Method precision was 0.58 %.  The method was found to linear (R=0.99996) in the Concentration range of 35-105 μg/ml (50 to 150%). The accuracy was in between 99.50-99.91%. Keywords:  HPLC, Correlation coefficient, System suitability, Bias, % RSD and ICH guidelines