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Application of Ion-Trap Mass Spectrometry for Identification and Structural Determination of an Unknown Impurity in Simvastatin

Application of Ion-Trap Mass Spectrometry for Identification and Structural Determination of an Unknown Impurity in Simvastatin

G V Ram Reddy, A Praveen Kumar, B Venkateswara Reddy, J Sreeramulu

Pharmazie. 2009 Oct;64(10):638-41.

PMID: 19947164

Abstract:

Anhydro-simvastatin and simvastatin dimer are the two main impurities in the fermentation broth as well as in the final product of simvastatin, which is a hypolipidemic drug. An unknown impurity with m/z 451 for [(M + H)(+)] was detected in the analysis of final simvastatin drug sample. By using reverse phase high performance liquid chromatography (HPLC)-mass spectrometry (MS) and MS/MS spectra, the unknown impurity was detected and identified. Separation was achieved on ACE-5 C18 (150 x 4.6 mm, 3 microm column) at the flow rate of 1.2 ml min(-1) applying gradient elution of mobile phase A consisting of Milli-Q water of pH 3.0 with formic acid and B consisting of acetonitrile. MS/MS spectrum of the unknown impurity was obtained using HPLC-MS equipped with positive electrosoray ionization (ESI). The unknown impurity is named as 7-[7-(2,2-dimethyl-butyryloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydro-naphthalen-1 -yl]-3-hydroxy-5-hydroxymethyl-heptanoic acid.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP210980680	Anhydro simvastatin		210980-68-0	Price

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