Reverse Phase High Performance Liquid Chromatography Method Development and Validation for Estimation of Benazepril and Hydrochlorothiazide HCL in Pure and Pharmaceutical Dosage Form

Abstract

A novel, accurate, and reproducible reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Benazepril and Hydrochlorothiazide HCl in pure form and pharmaceutical dosage formulations. Chromatographic separation was achieved using a Waters HPLC system equipped with an autosampler and PDA detector (996 model), on an Altima C18 column (4.6 × 150 mm, 5 µm) maintained at 35°C. The optimized mobile phase consisted of Water: Methanol: Acetonitrile (25:65:10 v/v/v), delivered at a flow rate of 1 mL/min. Detection was carried out at 265 nm, with an injection volume of 10 µL and a total run time of 14 minutes. The method was validated as per ICH guidelines, showing excellent linearity, accuracy, precision, specificity, and robustness. The results confirmed that the proposed method is suitable for routine quality control analysis of Benazepril and Hydrochlorothiazide HCl in bulk and combined dosage forms.