Detection of sulfur-containing impurities in pharmaceutical samples by high performance liquid chromatography/chemical reaction interface mass spectrometry

This paper describes the use of chemical reaction interface mass spectromet ry (CRIMS) combined with liquid chromatography for the detection of trace l evel sulfur-containing impurities in pharmaceutical materials. A mixture of sulfur- and non-sulfur-containing compounds were analyzed initially to tes t the system. Then the determination of trace level impurities in a cimetid ine drug substance was carried out. Detection of sulfur-containing impuriti es at less than 0.1% of the major component was obtained with good linearit y. The results obtained are consistent with the expected results for this s ample and illustrate the applicability of the technique. Copyright (C) 2001 John Wiley & Sons, Ltd.