Quantification and Method Validation of Enalapril Maleate by Using Rp-Hplc

Abstract

A rapid, economical, and highly accurate RP-HPLC method was established for the determination of enalapril maleate in both bulk drug and pharmaceutical formulations. Analysis was carried out using a Waters system equipped with an INTERSIL C-18 ODS column (250 × 4.6 mm, 5 μm particle size). The mobile phase consisted of acetonitrile and water in an 80:20 ratio, delivered at a flow rate of 1 ml/min, with detection at 208 nm. The retention time was observed at 3.2 minutes. The method exhibited linearity in the concentration range of 20–120 μg/ml, with a correlation coefficient of 0.9994. Sensitivity was high, with a limit of detection (LOD) of 0.1 μg/ml and a limit of quantification (LOQ) of 0.3 μg/ml. Validation followed International Conference on Harmonization (ICH) guidelines, and the method proved effective for the quantification of marketed formulations.