High-performance liquid chromatography of benzodiazepines I: Stability-indicating assay of diazepam tablets. 1979

M Emery, and J Kowtko

A high-performance liquid chromatographic procedure was developed for diazepam tablet analysis. This procedure separates the manufacturing intermediate, 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one, and the decomposition products, 3-amino-6-chloro-1-methyl-4-phenylcarbostyril and 2-methylamino-5-chlorobenzophenone, from diazepam. The liquid chromatographic procedure is superior to the USP UV assay because it is stability indicating. The method is simple, accurate, and fast, involving only one extraction step. A reversed-phase column and a methanol-water mobile phase were used. Under these conditions, 0.1% of the decomposition products was detectable. Typical samples of diazepam tablets showed no degradation.

UI MeSH Term Description Entries
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D003975 Diazepam A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity. 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one,Apaurin,Diazemuls,Faustan,Relanium,Seduxen,Sibazon,Stesolid,Valium
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet

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