Isolation of oxidative degradation products of atorvastatin with supercritical fluid chromatography |
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Authors: | Slavko Klob?ar Helena Prosen |
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Affiliation: | 1. KRKA d.d., Novo mesto, Slovenia;2. University of Ljubljana, Faculty of Chemistry and Chemical Technology, Ljubljana, Slovenia |
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Abstract: | The isolation of four oxidative degradation products of atorvastatin using preparative high‐performance liquid chromatography applying at least two chromatographic steps is known from the literature. In this paper it is shown that the same four impurities could be isolated from similarly prepared mixtures in only one step using supercritical fluid chromatography. The methods for separation were developed and optimized. The preparation of the mixtures was altered in such a way as to enhance the concentration of desired impurities. Appropriate solvents were applied for collection of separated impurities in order to prevent degradation. The structures of the isolated impurities were confirmed and their purity determined. The preparative supercritical fluid chromatography has proven to be superior to preparative HPLC regarding achieved purity of standards applying fewer chromatographic as well as isolation steps. Copyright © 2015 John Wiley & Sons, Ltd. |
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Keywords: | supercritical fluid chromatography atorvastatin impurities oxidative degradation preparative chromatography |
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