UPLC method development and validation for simultaneous determination of amlodipine besylate and enalapril maleate in drug products

Abstract

Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Amlodipine besylate and Enalapril maleate in pharmaceutical dosage form. Methods: Chromatogram was run through BEH C18 column (2.1 × 50mm i.d., 1.7 μm particle size). Mobile phase containing methanol: 1N HCl (1:1) was pumped through column at a flow rate of 1ml/min. Temperature was maintained at Ambient. Optimized wavelength for Amlodipine besylate and Enalapril maleate was 272 nm. Results: Retention time of Amlodipine besylate and Enalapril maleate were found to be 1.04 min and 0.59 min. The % purity of Amlodipine besylate and Enalapril maleate was found to be 100.03 % and 99.75 % respectively. The system suitability parameters for Amlodipine besylate and Enalapril maleate such as theoretical plates were found to be 5659.11 and 3214.07. the resolution was found to be 4.58,2.91. The linearity study for Amlodipine besylate and Enalapril maleate was found in concentration range of 10μg-50 μg and 10 μg-50 μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 97.41 % and 95.5 %, %RSD for repeatability was 0.73 and 0.66 %.