化学工学およびプロセス技術ジャーナル
オープンアクセス

概要

Characterization of Novel Stress Degradation Products of Bempedoic Acid and Ezetimibe using UPLC-MS/MS: Development and Validation of Stability indicating UPLC Method

Chemical Engineering in Food Industry

A receptive and easily comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe in tablet formulation by using UPLC. This technique involves the chromatographic separation with a C18 column of water symmetry (150mmx4.6mm, 3.5µ).A movable phase of 0.1% OPA (Ortho phosphoric acid) and acetonitrile in 50:50 v/v with 1mL/min flow rate and ambient temperature was used. UV observation was taken at 230 nm. Good results were obtained using these conditions of linearity over a range of 18-360 µg/mL of Bempedoic acid and 1-20 µg/mL of Ezetimibe using UPLC. By employing the above mentioned assay method, the results of other validation parameters of UPLC like system precision, method precision, accuracy, robustness and degradation studies were achieved within the permitted limit, according to ICH guidelines.