Ce. Sangervandegriend et K. Groningsson, VALIDATION OF A CAPILLARY ELECTROPHORESIS METHOD FOR THE ENANTIOMERICPURITY TESTING OF ROPIVACAINE, A NEW LOCAL-ANESTHETIC COMPOUND, Journal of pharmaceutical and biomedical analysis, 14(3), 1996, pp. 295-304
A capillary electrophoresis method for the determination of the enanti
omeric purity of ropivacaine, a new local anaesthetic compound develop
ed by Astra Pain Control AB, has been validated. The method showed the
required limit of quantitation of 0.1% enantiomeric impurity and prov
ed to be robust. Good performances were also shown for specificity, li
nearity, system repeatability and accuracy. The same capillary electro
phoresis method can also be used to simultaneously chirally resolve ho
mologues and impurities of ropivacaine.