Open AccessIsolation, Identification and Characterization of Degradation Impurity of Atorvastatin in Fixed Dose Combination of Atorvastatin and Ezetimibe
Author(s) -
Rajesh Desai,
Suresh Koradia
Publication year - 2019
Publication title -
international journal of pharmaceutical sciences and drug research
Language(s) - English
Resource type - Journals
ISSN - 0975-248X
DOI - 10.25004/ijpsdr.2019.110506
Subject(s) - ezetimibe , atorvastatin , impurity , degradation (telecommunications) , forced degradation , chromatography , chemistry , fixed dose combination , high performance liquid chromatography , materials science , organic chemistry , pharmacology , reversed phase chromatography , medicine , statin , biochemistry , computer science , telecommunications
The objective of this study is to isolation and characterization of unknown degradation product of Atorvastatin calcium in combination formulation product with Ezetimibe by using modern techniques of separation and aracterization. An unknown impurity is generating during a forced degradation study of Atorvastatin and Ezetimibe fixed-dose combination tablets. By using the gradient reversed-phase high-pressure liquid chromatographic method, unknown degradation impurity was detected and quantified in the range of 0.05% to 0.2% of Atorvastatin. The impurity was enriched by extreme oxidation degradation of Atorvastatin and isolated through preparative HPLC. The structure of the impurity was characterized by mass and NMR spectrum.