Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP

An unknown impurity in the fermentation-based drug substance lovastatin at 0.52 RRT was observed invariably in all batches when analyzed by HPLC as per the PhEur monograph. This impurity was isolated from the impurity-enriched sample using reversed-phase preparative HPLC and characterized by using s...

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Detalles Bibliográficos
Autores principales: Belwal, Chandrakant, Goyal, Praveen Kumar, Balte, Anup, Kolhe, Sandeep, Chauhan, Kamlesh, Rawat, Ajay Singh, Vardhan, Anand
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Österreichische Apotheker-Verlagsgesellschaft 2014
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3951232/
https://www.ncbi.nlm.nih.gov/pubmed/24634841
http://dx.doi.org/10.3797/scipharm.1305-04
Descripción
Sumario:An unknown impurity in the fermentation-based drug substance lovastatin at 0.52 RRT was observed invariably in all batches when analyzed by HPLC as per the PhEur monograph. This impurity was isolated from the impurity-enriched sample using reversed-phase preparative HPLC and characterized by using spectroscopic (PMR, CMR, MASS, and UV) techniques as the structurally-related compound Monacolin-X, having the molecular formula C(24)H(34)O(6) and the chemical name 2-methyl-3-oxobutanoic acid 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl ester.

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