A CHIRAL CAPILLARY ELECTROPHORESIS METHOD FOR ROPIVACAINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATIONS - VALIDATION AND COMPARISON WITH CHIRAL LIQUID-CHROMATOGRAPHY

Authors
SANGERVANDEGRIEND CE WAHLSTROM H GRONINGSSON K WIDAHLNASMAN M
Citation
Ce. Sangervandegriend et al., A CHIRAL CAPILLARY ELECTROPHORESIS METHOD FOR ROPIVACAINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATIONS - VALIDATION AND COMPARISON WITH CHIRAL LIQUID-CHROMATOGRAPHY, Journal of pharmaceutical and biomedical analysis, 15(8), 1997, pp. 1051-1061
Citations number
25
Categorie Soggetti
Pharmacology & Pharmacy
Journal title
Journal of pharmaceutical and biomedical analysis → ACNP
ISSN journal
07317085
Volume
15
Issue
8
Year of publication
1997
Pages
1051 - 1061
Database
ISI
SICI code
0731-7085(1997)15:8<1051:ACCEMF>2.0.ZU;2-3
Abstract
A capillary electrophoresis method for the determination of the enanti omeric purity of the local anaesthetic ropivacaine hydrochloride in in jection solutions has been validated. The method showed the required l imit of quantitation of 0.1% enantiomeric impurity. Good performances were shown for specificity, linearity, system repeatability, intermedi ate precision and accuracy. Robustness was tested via a full factorial design at two levels and the method proved to be robust. Comparison o f the capillary electrophoresis method with the liquid chromatographic method currently used for several years at our laboratory on real sam ples of ropivacaine injection solutions showed that the techniques do not give significantly different results. (C) 1997 Elsevier Science B. V.