毛细管气相色谱法测定盐酸金刚乙胺片含量

Capillary Gas Chromatography for Determination the Content of Rimantadine Hydrochloride Tablets

目的:建立气相色谱法测定盐酸金刚乙胺片的含量。方法:采用HP—1石英毛细管柱(30 m×0.32 mm×1.00μm,相当于SE-30),以盐酸金刚烷胺为内标物,检测器:氢火焰离子化检测器(FID),柱温:程序升温,初始温度130℃,保持5 min,以6℃·min^(-1)升至200℃,保持5 min。进样器温度:250℃;检测器温度:250℃;载气:氮气,流速:1.50 mL·min^(-1),分流比:1:50。结果:盐酸金刚乙胺的浓度在0.20—1.6 mg·mL^(-1)的范围内与峰面积呈良好的线性关系,r=1.0000;平均回收率(n=3)为100.6%,101.0%,101.8%。结论:本法专属性强、简便、准确,适用于盐酸金刚乙胺片的含量测定。

Objective: To develop a GC method for determining rimantadine hydrochloride content in tablets. Method: Using HP-1 quartz capillary column (30 m×0.32 mm×1.00μm , equivalent to SE-30). The internal standard was amantadine hydrochloride. Detector: FID; Column temperature: temperature programmed, initial temperature was kept at 130℃ for 5 min,then raised to 200℃ at the rate of 6℃·min^(-1) and kept for 5 min; Injector temperature; 250℃; Detector temperature: 250℃;Carrier gas: nitrogen; Flow rate: l.50 mL·min^(-1);Split ratio: 1: 50 . Results: Under this condition , there was a good linear relationship in the concentration range of 0.20-1.6 mg·mL^(-1); the correlation coefficient was 1.0000; the average recovery (n=3) were 100.6% , 101.0% , 101.8% . Conclusions: This method is selective,simple ,accurate and suitable for the determination of rimantadine hydrochloride tablets.