Identification of nifedipine metabolites and their determination by gas chromatography.

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Abstract
The urinary metabolites of nifedipine [NF; coronary vasodilator] in a dog were isolated and identified by chromatographic and spectrometric techniques. A new major metabolite, 2,6-dimethyl-4-(2-nitrophenyl)-5-methoxycarbonylpyridine-3-carboxylic acid (M-I), was found in both dog and human urine. A highly sensitive and specific method is described for the determination of NF, M-I, and a previously reported metabolite. The method for analysis of NF is based on the oxidation of NF to its pyridine analog, benzene extraction and determination by electron-capture gas chromatography. The method for analysis of the metabolites is based on ethyl acetate extraction of the acidified specimen, derivatization of M-I to its methyl ester and determination by electron-capture gas chromatography. Quantitative determination was possible down to 5 ng/ml of NF using 1 ml samples of biological specimens. This method was used to measure plasma levels of NF and its metabolites in dogs, and urinary excretion by humans after oral administration of a NF preparation. It was found that NF was absorbed, metabolized and excreted rapidly, and that the main metabolite was M-I.

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