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,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。

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.

[1] Calne DB.Advance in Neurology.New York:Raven Press,1973.105
[2] ChP(中国药典).2010.Vol Ⅱ(二部):737
[3] QIAN Ning-le(钱凝乐),GAO Dun-yu(高墩宇),TAO Zhou-rong(陶宙镕),et al.Acid dye colorimetry for determination of amantadine hydrochloride tablets(酸性染料比色法测定盐酸金刚烷胺片剂含量).Chin J Pharm Anal(药物分析杂志),1995,15(2):50
[4] RAO Yong-ping(饶永平).Determination of the dissolution of amantadine hydrochloride tablets(盐酸金刚烷胺片溶出度的测定).Fujian Anal Test(福建分析测试),2007,16(4):88
[5] XIU Hong(修虹),HUANG Rong-zhen(黄榕珍),FU Chun-mei(付梅春).Determination of amantadine hydrochloride and paracetamol in Qingke by HPLC-ELSD(HPLC-ELSD法测定复方氨酚烷胺胶囊中盐酸金刚烷胺及对乙酰氨基酚的含量).Drug Stand China(中国药品标准),2006,7(1):23
[6] WANG Qiao-e(王巧娥),DING Ming-yu(丁明玉).Progress on evaporative light-scattering detection(蒸发光散射检测技术研究进展).J Instrum Anal(分析测试学报),2006,25(6):126