Development and Validation of a Reverse Phase-High Performance Liquid Chromatography Method for the Assay of Benazepril Hydrochloride using a Quality-By-Design Approach

The current research involves using quality by design approaches to develop and validate a stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for chosen Benazepril hydrochloride (HCl). The RP-HPLC method’s quality target method profile and critical analytical attributes (CAAs) were determined. For benazepril, method optimization was carried out utilizing a central composite design that took into account buffer concentration and pH, flow rate, and percent organic modifier. From risk assessment and factor screening tests, flow rate, water concentration, and column tem-perature were identified as key method parameters (CMPs) and investigated for their impact on retention time (RT) and tailing factor (TF) for benazepril HCl as CAAs. Benazepril HCl was separated using a Waters Atlantis T3 column (250 ×4.6 mm × 5 m) with mobile phase in the ratio of 59 mM potassium phosphate buffer (pH 5.4):methanol (69:31), at a flow rate of 0.59 mL/min., with UV detection at 225 nm and using acetonitrile: water (60:40) at a flow rate of 1.1 mL/min, with UV detection at 237 nm, respectively. The RT of Benazepril HCl was discovered to be 2.25 min. According to ICH guidelines, the developedmethod was validated. The method’s linearity, specificity, accuracy, and precision were all validated, and the results were satisfactory. The method is cost-effective, precise, accurate, and linear at concentrations ranging from 50 to 350 ng/mL for benazepril HCl.