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Development and validation of a capillary electrophoresis method for the enantiomeric purity determination of SLV307,
Pim G Muijselaar1, Norbert G F M Lammers, Thijs K Gerding
1Solvay Pharmaceuticals B. V., Chemical and Pharmaceutical Development, Weesp, The Netherlands. pim.muijselaar@solvay.com
Abstract:
A capillary electrophoresis method for the enantiomeric purity determination of SLV307, a basic potential antipsychotic compound, has been developed and validated. It is shown that the presence of the eutomer in the sample solution may have a significant effect on the peak shape of the distomer, due to electrodispersion. The method is shown to give good performance with respect to the validation parameters specificity, linearity, accuracy, precision, determination limits, stability of solutions, and robustness of extraction.
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