Validation of a capillary electrophoresis method for the enantiomeric purity testing of ropivacaine, a new local anaesthetic compound

A capillary electrophoresis method for the determination of the enantiomeric purity of ropivacaine, a new local anaesthetic compound developed by Astra Pain Control AB, has been validated. The method showed the required limit of quantitation of 0.1% enantiomeric impurity and proved to be robust. Good performances were also shown for specificity, linearity, system repeatability and accuracy. The same capillary electrophoresis method can also be used to simultaneously chirally resolve homologues and impurities of ropivacaine.