SIMPLE AND STABILITY INDICATING RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION FOR ENALAPRIL MELIATE BY RP-HPLC IN BULK AND DOSAGE FORM

Abstract

A new simple, accurate, precise, sensitive and validated RP-HPLC method was developed for the estimation of Enalapril Meliate in bulk and pharmaceutical dosage form. The Chromatographic conditions used for the separation was X Bridge C18 (50 mm x4.6 mm, 3.5µm) and the mobile phase comprised of Ammonium dihydrogen ortho phosphate Buffer and Acetonitril(70:30 v/v). The flow rate was 0.6 ml/min The detection was carried out at 210 nm. The Assay method was validated as per ICH guidelines. The linearity was found to be in the range of 0.2 – 1.2 mg/ml (25% to 150%) with correlation coefficient(r) 0.9986. The proposed method is accurate with 99.76% - 99.98% recovery for Enalapril Meliate and precise. %RSD of repeatability, intraday and inter day variations were 0.074 - 0.372. The method can be used for the analysis of pharmaceutical formulation.