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

机译:静态空间气相色谱法测量盐酸硫胺素残留溶剂

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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.
机译:研究了测定硫胺素残留溶剂的快速一般方法。本文证明了具有火焰电离检测(FID)或质谱(MS)的静态顶空气色谱(HS / GC),用于测定药物产品中的挥发性残留溶剂。研究了分析方法性能特征,包括重复性,准确性和测定的检测限。结果表明,该方法具有非常良好的敏感性(检测限度下为9.45℃/ ml),精确(下面为7.35%RSD),适用于所有溶剂。甲醇,乙醇,N,N-二甲基甲酰胺和乙醚的回收率分别为98.59%,95.25%,95.25%,103.89%和99.88%。

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