Measurement of Residual Solvents in Thiamine Hydrochloride by Static Headspace Gas Chromatography

摘要

A rapid general method for the determination of residual solvents in thiamine was studied. This paper demonstrated static headspace gas chromatography (HS/GC) with either flame ionization detection (FID) or mass spectrometry (MS) for the determination of volatile residual solvents in pharmaceutical products. The analytical method performance characteristics were investigated, including the repeatability, the accuracy and the detection limit of determination. The results showed that the method had very good sensitivities (detection limits under 9.45 g/mL) and precision (under 7.35% RSD) for all solvents. The rates of recovery were 98.59%, 95.25%, 103.89% and 99.88% for methanol, ethanol, N, N-dimethyllformamide and ethyl ether, respectively.