Separation and quantification of ropinirole and some impurities using capillary liquid chromatography |
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Authors: | Pavel Coufal Karel
tulík Henk A Claessens Martin J Hardy Michael Webb |
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Institution: | a Department of Analytical Chemistry, Faculty of Science, Charles University, Albertov 2030, 128 40 Prague 2, Czech Republic;b Laboratory for Instrumental Analyses, Eindhoven Technical University, P.O. Box 513, 5600 MB Eindhoven, The Netherlands;c Analytical Sciences, SmithKline Beecham Pharmaceuticals, Third Avenue, The Pinnacles, Harlow, Essex CM19 5AD, UK |
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Abstract: | Ropinirole, 4-2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one, is a potent anti-Parkinson’s disease drug developed by SmithKline Beecham Pharmaceuticals. Capillary liquid chromatography (CLC) was used for the separation and quantification of ropinirole and its five related impurities, potentially formed during its synthesis. A simultaneous optimization of three mobile phase parameters, i.e., pH, buffer concentration and acetonitrile content was performed employing an experimental design approach which proved a powerful tool in method development. The retention factors of the investigated substances in different mobile phases were determined. Baseline resolution of the six substances on a C18 reversed stationary phase was attained using a mobile phase with an optimized composition acetonitrile–8.7 mM 2-(N-morpholino)ethanesulfonic acid adjusted to pH 6.0 (55:45, v/v)]. It was shown that CLC, operated in the isocratic mode under the mobile phase flow-rate of 4 μl/min, can determine the level of these impurities, down to a level of 0.06% of the main component within 25 min. |
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Keywords: | Ropinirole |
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