HPLC-ELSD法测定盐酸金刚烷胺片的溶出度
HPLC-ELSD determination of dissolution of amantadine hydrochloride tablets
分类号:
出版年·卷·期(页码):2012,32 (1):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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,5 μm)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39.56~197.8 μg·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。
-----英文摘要:---------------------------------------------------------------------------------------
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.
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