METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF AMLODIPINE AND ENALAPRIL MALEATE IN ACTIVE PHARMACEUTICAL INGREDIENT AND COMBINED TABLET DOSAGE FORM BY RP-HPLC

Abstract

  A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Amlodipine and Enalapril maleate, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Altima C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 225 nm. The retention time of the Amlodipine and Enalapril maleate was 2.102, 3.537 ±0.02min respectively. The method produce linear responses in the concentration range of 5-25mg/ml of Amlodipine and 12.5-62.5mg/ml of Enalapril maleate. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.