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目的建立HPLC-ELSD法测定感愈胶囊中盐酸金刚烷胺及对乙酰氨基酚的含量的方法。方法采用CAPCELL PAK MGⅡC18(4.6mm×150mm,5μm)色谱柱,流动相为乙腈-0.06%三氟乙酸溶液(20∶80),流速0.6m L·min-1,柱温30℃,进样量10μL,ELSD检测器漂移温度为100℃,雾化气体为空气,气流速度为2.0L·min-1。结果盐酸金刚烷胺和对乙酰氨基酚分别在2.1184~12.7104μg、4.9736~29.8416μg范围内进样量与峰面积的对数具有良好线性关系(r=0.9999,0.9999);二者平均回收率分别为99.55%和100.07%,RSD分别为1.24%,0.97%(n=6)。结论本法简便、准确、分离效果好,可用于感愈胶囊的质量控制。
OBJECTIVE To establish a HPLC-ELSD method for the determination of amantadine hydrochloride and acetaminophen in the Yusu capsule. Methods The mobile phase consisted of acetonitrile-0.06% trifluoroacetic acid (20:80) with a flow rate of 0.6 mL · min-1 using a CAPCELL PAK MGⅡC18 column (4.6 mm × 150 mm, 5 μm) 10μL, ELSD detector drift temperature of 100 ℃, atomized air is air, the air flow rate of 2.0L · min-1. Results There was a good linear relationship (r = 0.9999,0.9999) between the injection volume of amantadine hydrochloride and paracetamol in the range of 2.1184 ~ 12.7104μg and 4.9736 ~ 29.8416μg, respectively. The average recoveries With 99.55% and 100.07% respectively, with RSDs of 1.24% and 0.97%, respectively (n = 6). Conclusion This method is simple, accurate, good separation effect, can be used for quality control of capsules.