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 spectrometry (CRIMS) combined with liquid chromatography for the detection of trace level sulfur-containing impurities in pharmaceutical materials. A mixture of sulfur- and non-sulfur-containing compounds were analyzed initially to test the system. Then the determination of trace level impurities in a cimetidine drug substance was carried out. Detection of sulfur-containing impurities at less than 0.1% of the major component was obtained with good linearity. The results obtained are consistent with the expected results for this sample and illustrate the applicability of the technique.
Eckers
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C
GlaxoSmithKline, NFSP(N), Harlow CM19 5AW, UK.
Abramson
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FP
Lecchi
P
P
D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D013058:Mass Spectrometry; D012015:Reference Standards; D012996:Solutions; D013457:Sulfur Compounds / Q000032:analysis*
D012996:Solutions; D013457:Sulfur Compounds