Home > Technical Articles > Lovastatin
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Home > Technical Articles > Lovastatin
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| Red Yeast Rice is the product of
fermentation of certain strains of yeast (Monascus spp.) on rice. It has
been used in traditional Chinese medicine to support circulatory health,
and some studies have indicated that it may reduce serum cholesterol and
lipids in some people. This appears to be due to the presence of
hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known
as statins. Lovastatin is the best known of these naturally occurring
compounds, and a host of semi-synthetic derivatives are now in use as
cholesterol-lowering drugs (e.g. Zocor).
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Lovastatin
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FDA PositionIn 1998, FDA determined that certain proprietary red yeast rice products were unapproved drugs, not dietary supplements. The case has been in the courts, and the regulatory future of red yeast rice supplements is unclear. Because this uncertainty is due to the presence of lovastatin in the supplements, it has become important to be able to analyze these complex mixtures for lovastatin. |
HPLC with UV detection is the currently accepted method for lovastatin tablets; however, red yeast rice products are much more complex and subject to interferences. Therefore, WCAS has developed an LC-MS/MS method for this analysis. MS/MS is an extremely specific and sensitive method of detection. Additionally, the use of MS/MS enables the use of a chemically similar internal standard, further improving the accuracy and precision of the analysis.
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LC-MS/MS AnalysisIn this method, an aliquot of sample is spiked with the internal standard (simvastatin, a semi-synthetic analog of lovastatin), then extracted with methanol. The filtered extract is analyzed on a fast (50 x 2mm) LC column using a steep gradient. The lovastatin and internal standard elute within 4 minutes. |
The method shows good linearity over a wide range, important due to the wide variability in lovastatin concentrations in supplements. Analysis of spiked samples give an average recovery of 85% (n=13). |
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