title: Liquid chromatographic methods for assay of carbamazepine, 10,11-dihydrocarbamazepine, and related compounds in carbamazepine drug substance and tablets.
abstract: 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.
authors: Health and Welfare Canada, Bureau of Drug Research, Ottawa, Ontario.
authors: T D
authors: TD
authors: Cyr
authors: F
authors: F
authors: Matsui
authors: R W
authors: RW
authors: Sears
authors: N M
authors: NM
authors: Curran
authors: E G
authors: EG
authors: Lovering
mesh_terms: D002220:Carbamazepine / Q000031:analogs & derivatives* / Q000032:analysis*; D002849:Chromatography, Gas; D002853:Chromatography, Liquid; D002855:Chromatography, Thin Layer; D007202:Indicators and Reagents; D013607:Tablets
chemical_list: D007202:Indicators and Reagents; D013607:Tablets; D002220:Carbamazepine; C054135:10,11-dihydrocarbamazepine