RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE IN TABLET

The present study outlines the development and validation of a simple, precise, accurate, and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Enalapril Maleate and Hydrochlorothiazide in tablet dosage form. The chromatographic separation was achieved using a Kromasil C18 column (250mm × 2.1mm, 1.5 µm) with a mobile phase consisting of Methanol: Acetonitrile: Ammonium Acetate Buffer (pH 4.5) in the ratio of 40:30:30 v/v, at a flow rate of 1.0 ml/min and detection wavelength of 230 nm. The retention times of Enalapril Maleate and Hydrochlorothiazide were found to be 3.841 and 5.652 minutes, respectively. The method was validated according to ICH guidelines for parameters including linearity, accuracy, precision, specificity, robustness, ruggedness, LOD, and LOQ. Linearity was observed in the range of 5–30 µg/mL for both drugs with correlation coefficients greater than 0.999. Recovery studies indicated accuracy within the acceptable limits. The method demonstrated suitable system suitability parameters with acceptable resolution, tailing factor, and theoretical plate count. The proposed RP-HPLC method is suitable for routine quality control of Enalapril Maleate and Hydrochlorothiazide in bulk and pharmaceutical dosage forms.

Keywords: Enalapril Maleate, Hydrochlorothiazide, RP-HPLC, Method Development, Method Validation, Simultaneous Estimation, ICH Guidelines, Linearity, Accuracy, Precision, Pharmaceutical Dosage Form