气相色谱法测定小儿氨酚烷胺颗粒中盐酸金刚烷胺的含量

摘要

Objective:To establish a GC method for determining the content of amantadine hydrochloride in pediatric paracetamol and amanatadine hydrochloride granules. Methods:The ingredients were separated on an Agilent DB-5 quartz capillary column (30 m ×0.25 mm, 0.25 μm), the carrier gas was N2,and the flow rate was 1 ml·min-1. The column temperature was maintained at 130℃, the injection temperature was 250℃,the detection temperature was 280℃ with an FID as the detector , the injection volume was 2 μl, and the split ratio was 20∶1. Results:A good linear relationship was obtained between the peak area and the concentration of amantadine hydrochloride within the range from 0.103 2 to 6.456 0 mg·ml-1(r =0.999 9). The average recovery was 100.18%(RSD=0. 11%, n=6). Conclusion:The method is specific, accurate, reliable and reproducible, which can be used in the quality control of pediatric paracetamol and amanatadine hydrochloride granules.%目的：：建立以气相色谱法测定小儿氨酚烷胺颗粒中盐酸金刚烷胺的含量方法。方法：采用安捷伦 DB-5毛细管柱(30 m ×0.25 mm,0.25μm)；载气为氮气,流速1 ml·min-1,柱温130℃,进样口温度为250℃,检测器温度为280℃,FID 氢火焰离子化检测器,进样量2μl,分流比20∶1。结果：盐酸金刚烷胺在0.1032~6.4560 mg·ml-1范围内质量浓度与峰面积线性关系良好(r=0.9999),平均回收率为100.18%(RSD为0.11%,n=6)。结论：该方法专属性强,准确可靠,重复性好,可用于控制制剂的质量。