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Sci. Pharm. 2014, 82(1), 43-52; doi:10.3797/scipharm.1305-04

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

Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India
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Received: 2 May 2013 / Accepted: 1 July 2013 / Published: 1 July 2013
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Abstract

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 C24H34O6 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.
Keywords: Lovastatin; Isolation; Identification; Characterization; Chromatography; Prep HPLC Lovastatin; Isolation; Identification; Characterization; Chromatography; Prep HPLC
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

BELWAL, C.; GOYAL, P.K.; BALTE, A.; KOLHE, S.; CHAUHAN, K.; RAWAT, A.S.; VARDHAN, A. Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP. Sci. Pharm. 2014, 82, 43-52.

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