Determination of Dimethylamine and Triethylamine in Hydrochloride Salts of Drug Substances by Headspace Gas Chromatography using Dimethyl Sulphoxide-imidazole as Diluent
نویسندگان
چکیده
A simple, rapid, accurate and precise analytical method for determination of secondary and tertiary amines in hydrochloride salt form of drug substances in non-aqueous medium, which does not require any derivatization, was developed by headspace gas chromatography. Dimethylamine hydrochloride and triethylamine hydrochloride were analyzed in metformin hydrochloride. The sample was dissolved in a vial containing dimethyl sulphoxide and imidazole. The vials were incubated at 100°, for 20 min. The syringe temperature was maintained at 110°. DB624 column with 30 m×0.32 mm i.d., 1.8 μm film thickness was used. The injector and detector temperature were 200° and 250°, respectively. The analytical program used was carrier gas (nitrogen) flow rate: 1 ml/min; injected gas volume: 1.0 ml; split ratio: 1:10; oven temperature program: 40° for 10 min, followed by an increase up to 240° at 40°/min. The analytical method was validated with respect to precision, recovery, limit of detection and quantification and linearity.
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