Liquid chromatographic methods for assay of carbamazepine, 10,11-dihydrocarbamazepine, and related compounds in carbamazepine drug substance and tablets.
Liquid chromatographic (LC) methods have been developed for the determination of carbamazepine, the impurity 10,11-dihydrocarbamazepine, and related compounds in carbamazepine drug substance and tablets. The LC methods specify a 5 micron diol column and a mobile phase of acetonitrile-methanol-0.05% aqueous acetic acid (5 + 5 + 90). Iminodibenzyl and iminostilbene, starting materials for some routes of synthesis, elute late in the LC system; therefore, a thin-layer chromatographic method for their detection at the 0.05% level has been developed. Eight tablet and 13 raw material samples from several sources were examined. The impurities most frequently found were 10, 11-dihydrocarbamazepine and a compound identified as 10-bromocarbamazepine at levels up to 1.3 and 0.5%, respectively; minimum detectable amounts were about 0.01 and 0.03%, respectively.
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Health and Welfare Canada, Bureau of Drug Research, Ottawa, Ontario.
Matsui
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Sears
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Curran
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Lovering
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D002220:Carbamazepine / Q000031:analogs & derivatives* / Q000032:analysis*; D002849:Chromatography, Gas; D002853:Chromatography, Liquid; D002855:Chromatography, Thin Layer; D007202:Indicators and Reagents; D013607:Tablets
D007202:Indicators and Reagents; D013607:Tablets; D002220:Carbamazepine; C054135:10,11-dihydrocarbamazepine