HPLC-ELSD法测定盐酸金刚烷胺片的溶出度

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。

HPLC-ELSD determination of dissolution of amantadine hydrochloride tablets

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% trifluoroacetic 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.