Monitoring a potential carcinogen in pharmaceutical formulations at the low part per billion level. High-performance liquid chromatographic determination of N-nitrosohexamethyleneimine in tolazamide.
A method is described for the determination of N-nitrosohexamethyleneimine, a potential carcinogen, in tolazamide bulk drug and pharmaceutical dosage forms. The technique of trace enrichment high-performance liquid chromatography is employed to obtain accurate quantitation of the analyte at levels approaching 1 ppb. Following extraction in diethyl ether and on-line cleanup and enrichment, the nitrosamine is detected by UV at 228 nm.
D002021:Buffers; D002273:Carcinogens / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D007202:Indicators and Reagents; D009602:Nitrosamines / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet; D014042:Tolazamide / Q000032:analysis*
D002021:Buffers; D002273:Carcinogens; D007202:Indicators and Reagents; D009602:Nitrosamines; C002742:N-nitrosoperhydroazepine; D014042:Tolazamide