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HPLC法测定非洛地平缓释片释放度的探讨
引用本文:庾莉菊,余振喜,湛建锋,张启明.HPLC法测定非洛地平缓释片释放度的探讨[J].中国药事,2009,23(6):532-534.
作者姓名:庾莉菊  余振喜  湛建锋  张启明
作者单位:1. 中国药品生物制品检定所,北京,100050
2. 湖南省岳阳药品检验所
摘    要:目的建立HPLC法测定非洛地平缓释片释放度的方法。方法采用Shim-pack VP-ODS C18柱,以乙腈-甲醇-磷酸盐缓冲液(2∶1∶2)为流动相;流速:1.0mL.min-1;柱温:35℃;检测波长:254nm。结果非洛地平在0.513~20.52μg.mL-1范围内呈良好线性关系(r=0.9999),平均回收率为99.6%,RSD为0.6%。结论该法灵敏度高,结果准确,重现性好,适用于非洛地平缓释片的释放度测定。

关 键 词:HPLC  非洛地平  缓释片  释放度

Determination of Release of Felodipine Extended-Release Tablets in Vitro by HPLC
Yu Liju,Yu Zhenxi,Zhan Jianfeng,Zhang Qiming.Determination of Release of Felodipine Extended-Release Tablets in Vitro by HPLC[J].Chinese Pharmaceutical Affairs,2009,23(6):532-534.
Authors:Yu Liju  Yu Zhenxi  Zhan Jianfeng  Zhang Qiming
Institution:Yu Liju, Yu Zhenxi, Zhan Jianfeng and Zhang Qiming (National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050;1 Hunan Yueyang Institute for Drug Control)
Abstract:Objective To develop a method for determination of release of Felodipine Extended-release Tablets in vitro. Methods Felodipine was separated on Shim-pack VP-ODS C18 column, the mixture of acetonitrile-methanol-phosphate buffer (2 : 1 : 2) as mobile phase at a flow rate of 1.0mL^-1 min^-1, the detection wavelength was 254nm. Results The calibration curve was linear in the range of 0. 513-20.52μg ·mL^-1 (r= 0. 9999) . The average recovery was 99.6%, RSD was 0.6%(n= 5). Conclusions The method is sensitive, accurate and suitable for determination of release of Felodipine Extended-release Tablets in vitro.
Keywords:HPLC
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