High-performance liquid chromatographic and capillary electrophoretic methods for the quantitation of the (S)-terbutaline in (R)-terbutaline

초록

The resolution of chiral drugs, metabolites and related substances continues to be an important area in pharmaceutical analysis. Two methods for the optical purity testing of (R)-(-)-terbutaline were developed, namely capillary electrophoresis using hydroxypropyl-β-cyclodextrin and high-performance liquid chromatography using a chiral stationary phase. Validation data such as linearity, recovery, detection limit, and precision of the two methods are presented. The detection limit of (S)-terbutaline in (R)-terbutaline was 0.05% by the HPLC method and 0.03% by the CE method. There was generally good agreement between the HPLC and CE results. These methods were found to be applicable as a practical quality control method for the enantiomeric purity determination of (R)-terbutaline.

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