Original Articles: 2015 Vol: 7 Issue: 1
A novel stability indicating liquid chromatographic method development and validation for the simultaneous estimation of enalapril maleate and hydrochlorothiazide in bulk and pharmaceutical formulations
A simple, precise, accurate, reproducible and economical stability- indicating reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of Enalapril Maleate and Hydrochlorothiazide in bulk and marketed formulations. Estimation of drugs in this combination was done with a C18 column [ ODS UG column. 250mm × 4.5 mm]using mobile phase of composition Acetate buffer, Methanol and Acetonitrile (60:20:20 v/v, pH 5).The flow rate was 0.8 ml/min and the effluents were monitored at 232nm. The retention time of Enalapril Maleate and Hydrochlorothiazide were2.8 min and 4.1 min respectively. The method was found to be linear over a range of 10-30 mg/ml for Enalapril Maleate and Hydrochlorothiazide. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations.