A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: validation and comparison with chiral liquid chromatography.
A capillary electrophoresis method for the determination of the enantiomeric purity of the local anaesthetic ropivacaine hydrochloride in injection solutions has been validated. The method showed the required limit of quantitation of 0.1% enantiomeric impurity. Good performances were shown for specificity, linearity, system repeatability, intermediate precision and accuracy. Robustness was tested via a full factorial design at two levels and the method proved to be robust. Comparison of the capillary electrophoresis method with the liquid chromatographic method currently used for several years at our laboratory on real samples of ropivacaine injection solutions showed that the techniques do not give significantly different results.
Sänger-van de Griend
C E
CE
Department of Analytical Chemistry, Astra Pain Control AB, Södertälje, Sweden.
Wahlström
H
H
Gröningsson
K
K
Widahl-Näsman
M
M
D000577:Amides / Q000032:analysis*; D000779:Anesthetics, Local / Q000032:analysis*; D002853:Chromatography, Liquid; D004304:Dosage Forms; D019075:Electrophoresis, Capillary; D015203:Reproducibility of Results; D000077212:Ropivacaine; D012680:Sensitivity and Specificity; D013237:Stereoisomerism
D000577:Amides; D000779:Anesthetics, Local; D004304:Dosage Forms; D000077212:Ropivacaine