Add time:09/08/2019         Source:sciencedirect.com

The aim of this study was to optimize the high-performance liquid chromatographic separation of (6S,4R)-(−)-6-hydroxy-4-(1-hydroxy-1-methylethyl)-1-cyclohexene-1-ethanol and its potential impurities to determine them in the active ingredient and in pharmaceutical formulations for purity and stability analysis. A comparison of conventional normal- and reversed-phase high-performance liquid chromatographic analysis and a method employing β-eyclodextrin was made. The reversed-phase analysis without β-cyclodextrin was undoubtedly unsuitable for an acceptable high-performance liquid chromatographic separation. On the other hand the other two methods were more selective and showed good precision, accuracy and linearity in the range investigated. However the use of β-cyclodextrin as eluent modifier with a reversed-phase was preferable for its improved selectivity and also for allowing the use of a non-toxic and less expensive eluent. Also, the limits of detection and quantitation obtained for the impurities made the β-cyclodextrin method very suitable for purity and stability analysis.

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