盐酸金刚烷胺胶囊含量测定方法研究

摘要

目的：探索盐酸金刚烷胺胶囊的含量测定方法。方法应用 HPlc-elsd 法对盐酸金刚烷胺胶囊含量进行测定，色谱柱为 c18（4.6 mm×250 mm，5μm），流动相为乙腈-0.06%的三氟乙酸（20：80）,柱温为30℃，进样量为10μl,流速为1.0 ml· min-1。检测器：elsd ,漂移管温度：65℃，雾化气体：空气，载气流量：2.8 l·min-1。结果盐酸金刚烷胺在(39.62-237.72μg·ml-1)范围内进样量与峰面积的对数线性关系好（r=0.9993）；平均回收率：100.2%,（rsd=1.2%）。结论 HPlc-elsd 法样品处理便捷，准确，专属性强，是盐酸金刚烷胺胶囊的质量控制的优选。%Objective to establish a method for determination of the content of amantadine Hydrochloride capsules. Methods HPlc-elsd method was used to determine the content of amantadine Hydrochloride capsules. the column was c18 (4.6 mm * 250 mm, 5 m), the mobile phase was three -0.06% trifluoroacetic acid acetonitrile (20:80), the column temperature was 30 ℃ , the injection volume was 10 L, the flow rate was 1 mL - min - 1. Detector: ELSD, drift tube temperature: 65 ℃ , atomization gas: air, carrier gas flow rate: 2.8 L - min - 1. Results there was a good log linear relationship (r=0.9993) between the sample volume and peak area of amantadine hydrochloride in (39.62-237.72 G - ml - 1); the average recovery rate: 100.2%, (rsd=1.2%). Conclusion Treating sample with HPLC-ELSD method is convenient, accurate, specific, top exclusive and it is preferred for quality control in amantadine Hydrochloride capsules.