Journal of Chemical Engineering & Process Technology
Open Access
ISSN: 2157-7048
ISSN: 2157-7048
Department of Chemistry, Vignans NIRULA Institute of technology &Science, Guntur, AP-522009, India
Research Article
Characterization of Novel Stress Degradation Products of Bempedoic Acid and Ezetimibe using UPLC-MS/MS: Development and Validation of Stability indicating UPLC Method
Author(s): Subrahmanyam Talari, Anuradha* and Ch Rajani
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... View More»