RP-HPLC Method Development and Validation for Simultaneous Estimation of Propranolol and its Impurity

Abstract

A simple, precise, and accurate RP-HPLC method was developed and validated for the simultaneous determination of propranolol hydrochloride (PRH) and its impurity, propranolol EP impurity A (IMP), in pharmaceutical dosage forms. The method employed a Shim-Pack Solar C18 column (250 × 4.6 mm I.D., 5 μm particle size) with a mobile phase consisting of acetonitrile and methanol in a 40:60 v/v ratio at a flow rate of 1.0 mL/min. The detection wavelength was set at 273 nm. The method demonstrated linearity in the concentration range of 4–20 μg/mL for both PRH and IMP, with regression equations of y=10536x+3775.2 (R²=0.9988) and y=13256x–11610 (R²=0.9953), respectively. The intra-day and inter-day precision values, expressed as relative standard deviation (RSD), were less than 2%. The method showed excellent accuracy, with percentage mean recoveries ranging from 99.3% to 102.8%. The limits of detection (LOD) and quantification (LOQ) were found to be 0.907 and 2.748 μg/mL for PRH, and 0.934 and 2.830 μg/mL for IMP, respectively. The method was robust, specific, and selective, demonstrating its suitability for the quality control analysis of propranolol hydrochloride and its impurity in pharmaceutical formulations.