摘要
目的:采用HPLC-ELSD法建立盐酸金刚烷胺片溶出度的测定方法。方法:采用Agilent ZORBAX SB-C18(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-0.06%三氟乙酸溶液(20∶80),流速1.0 mL.min-1,柱温为30℃;使用ELSD检测器,漂移管温度为55℃,雾化气体为空气,载气流量为1.8 L.min-1。结果:盐酸金刚烷胺浓度在39.56～197.8μg.mL-1范围内线性关系良好(r=0.9996);平均回收率(n=9)为99.9%。结论:本方法准确、可靠,灵敏度高,适用于盐酸金刚烷胺片溶出度的检测。
Objective：To establish a method for the dissolution determination of amantadine hydrochloride tablets by HPLC -ELSD. Methods： The chromatographic condition was as follows： Agilent ZORBAX SB -C18 （250 mm × 4.6 mm, 5 μm） was adopted, the mobile phase was composed of acetonitrile -0. 06% trifluoroaeetic acid（20： 80） at the flow rate of 1.0 mL · min ^- 1, and the column temperature was 30 ℃ ; The condition of ELSD was as follows ： the temperature of tube was set at 55 ℃, nebulizer gas was air, the flow rate was 1.8 L · min^- 1. Results： The calibration curve showed a good linearity in the range of 39.56 - 197.8 μg · mL^-1 （ r = 0. 9996） ; The average recovery（ n = 9 ） was 99.9%. Conclusion：The method is accurate, reliable and sensitive, and can be applied for the dissolution determination of amantadine hydrochloride tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第1期159-162,共4页
Chinese Journal of Pharmaceutical Analysis
