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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0.103 2~6.456 0 mg·ml-1范围内质量浓度与峰面积线性关系良好(r=0.999 9),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。
Objective: To establish a gas chromatographic method for the determination of amantadine hydrochloride in children with paracetamol particles. Methods: The Agilent DB-5 capillary column (30 m × 0.25 mm, 0.25 μm) was used. The carrier gas was nitrogen and the flow rate was 1 ml · min-1. The column temperature was 130 ℃ and the inlet temperature was 250 ℃. 280 ℃, FID hydrogen flame ionization detector, injection volume 2μl, split ratio 20: 1. Results: The linear range of the concentration of amantadine hydrochloride in the range of 0.103 2 ~ 6.456 0 mg · ml-1 was linear (r = 0.999 9) and the average recovery was 100.18% (RSD = 0.11%, n = 6) . Conclusion: This method is highly specific, accurate and reliable, reproducible and can be used to control the quality of preparation.