A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: Validation and comparison with chiral liquid chromatography

C. E. Sänger-Van De Griend; H. Wahlström; K. Gröningsson; Monica E. Widahl-Näsman

doi:10.1016/S0731-7085(96)01994-2

A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: Validation and comparison with chiral liquid chromatography

C. E. Sänger-Van De Griend, H. Wahlström, K. Gröningsson, Monica E. Widahl-Näsman

BioAnalytical Chemistry

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	1051-1061
Number of pages	11
Journal	Journal of Pharmaceutical and Biomedical Analysis
Volume	15
Issue number	8
DOIs	https://doi.org/10.1016/S0731-7085(96)01994-2
Publication status	Published - May 1997

Keywords

Capillary electrophoresis
Enantiomer separation
Local anesthetics
Pharmaceutical analysis
Ropivacaine
Validation

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/S0731-7085(96)01994-2

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Sänger-Van De Griend, C. E., Wahlström, H., Gröningsson, K., & Widahl-Näsman, M. E. (1997). 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), 1051-1061. https://doi.org/10.1016/S0731-7085(96)01994-2

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title = "A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: Validation and comparison with chiral liquid chromatography",

abstract = "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.",

keywords = "Capillary electrophoresis, Enantiomer separation, Local anesthetics, Pharmaceutical analysis, Ropivacaine, Validation",

author = "{S{\"a}nger-Van De Griend}, {C. E.} and H. Wahlstr{\"o}m and K. Gr{\"o}ningsson and Widahl-N{\"a}sman, {Monica E.}",

year = "1997",

month = may,

doi = "10.1016/S0731-7085(96)01994-2",

language = "English",

volume = "15",

pages = "1051--1061",

journal = "Journal of Pharmaceutical and Biomedical Analysis",

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Sänger-Van De Griend, CE, Wahlström, H, Gröningsson, K & Widahl-Näsman, ME 1997, 'A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: Validation and comparison with chiral liquid chromatography', Journal of Pharmaceutical and Biomedical Analysis, vol. 15, no. 8, pp. 1051-1061. https://doi.org/10.1016/S0731-7085(96)01994-2

A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: Validation and comparison with chiral liquid chromatography. / Sänger-Van De Griend, C. E.; Wahlström, H.; Gröningsson, K. et al.
In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 15, No. 8, 05.1997, p. 1051-1061.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations

T2 - Validation and comparison with chiral liquid chromatography

AU - Sänger-Van De Griend, C. E.

AU - Wahlström, H.

AU - Gröningsson, K.

AU - Widahl-Näsman, Monica E.

PY - 1997/5

Y1 - 1997/5

N2 - 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.

AB - 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.

KW - Capillary electrophoresis

KW - Enantiomer separation

KW - Local anesthetics

KW - Pharmaceutical analysis

KW - Ropivacaine

KW - Validation

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ER -

A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: Validation and comparison with chiral liquid chromatography

Abstract

Keywords

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