A direct gas-chromatographic method for the determination of basic nitrogenous drugs in pharmaceutical preparations

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Abstract
A gas-chromatographic method has been developed for the direct assay of basic nitrogenous drugs, present as salts, in a range of pharmaceutical preparations. A glass column was packed with 3 per cent. silicone OV-17 on Gas-Chrom Q, 80 to 100 mesh, and maintained isothermally at temperatures within the range 200 to 270 °C, as appropriate for the drug to be determined. Calibration data are given for eighteen drugs, and the gas-chromatographic procedures have been subjected to a statistical evaluation. Five determinations performed on each of eight standard pharmaceutical preparations gave coefficients of variation of less than 2·2 per cent. The subsequent application of the method, based upon duplicate determinations, to a larger series of standard pharmaceutical preparations gave recoveries within the range 96 to 104 per cent. of the known concentration of the test drug. The procedure can now be used as part of a routine quality control specification in place of a variety of non-specific classical methods.

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