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Volume 82
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10.3797/scipharm.1305-04
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Article

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

by
Chandrakant BELWAL
,
Praveen Kumar GOYAL
*,
Anup BALTE
,
Sandeep KOLHE
,
Kamlesh CHAUHAN
,
Ajay Singh RAWAT
and
Anand VARDHAN
Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2014, 82(1), 43-52; https://doi.org/10.3797/scipharm.1305-04
Submission received: 2 May 2013 / Accepted: 1 July 2013 / Published: 1 July 2013
Versions Notes

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

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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. https://doi.org/10.3797/scipharm.1305-04

AMA Style

BELWAL C, GOYAL PK, BALTE A, KOLHE S, CHAUHAN K, RAWAT AS, VARDHAN A. Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP. Scientia Pharmaceutica. 2014; 82(1):43-52. https://doi.org/10.3797/scipharm.1305-04

Chicago/Turabian Style

BELWAL, Chandrakant, Praveen Kumar GOYAL, Anup BALTE, Sandeep KOLHE, Kamlesh CHAUHAN, Ajay Singh RAWAT, and Anand VARDHAN. 2014. "Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP" Scientia Pharmaceutica 82, no. 1: 43-52. https://doi.org/10.3797/scipharm.1305-04

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