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HPLC法测定草酸阿德福韦酯片溶出度
引用本文:王喜军,杨蕾.HPLC法测定草酸阿德福韦酯片溶出度[J].中外医疗,2013,32(17):18-19.
作者姓名:王喜军  杨蕾
作者单位:王喜军 (哈药集团制药总厂,黑龙江哈尔滨,150046); 杨蕾 (哈药集团制药总厂,黑龙江哈尔滨,150046);
摘    要:目的采用高效液相色谱法测定草酸阿德福韦酯片的溶出度。方法按照中国药典2010年版二部溶出度测定法中的第二法,以0.1mol/L HCl600mL为溶出介质,转速为50rpm,45min时采样,以高效液相色谱法测定。色谱柱:DiamonsilC18(150mm×4.6mm,5μm);流动相:甲醇-水-冰醋酸=50:50:0.1;流速:1.0mL/min;检测波长:258nm,以外标法测定草酸阿德福韦酯片的溶出度。结果线性范围为9.42~22.62μg/mL。平均回收率为100.2%。(RSD为0.50%,n=9),溶出度符合规定。结论该方法简便、易行,结果准确。

关 键 词:草酸阿德福韦酯片  溶出度  高效液相色谱法

Deter mination of dissolution of Adefovir Dipivoxil Oxalic Acid tablets by HPLC
WANG Xijun,YANG Lei.Deter mination of dissolution of Adefovir Dipivoxil Oxalic Acid tablets by HPLC[J].China Foreign Medical Treatment,2013,32(17):18-19.
Authors:WANG Xijun  YANG Lei
Institution:Harbin Pharmaceutical Group Co.Ltd.General Pharm.Factory of Harbin City,Heilongjiang Province,Harbin 150046,China
Abstract:Objective The research establish HPLC methods for dissolution of Adefovir Dipivoxil Oxalic Acid tablets.M ethods Perform the test according to apparatus II,the medium is 0.01mol/L hydrochloric acid,600ml,50rpm.The dissolution time is 45min.Use HPLC method for the determination.Diamonsil C18 column(150mm ×4.6mm,5μm) is used with methanol,water and glacial acetic acid(50:50:0.1) as the mobile phase,with flow rate of 1.0mL/min and the detection wavelength of 258nm.Results The linear range of Adefovir Dipivoxil is 9.42~22.62 μg/mL,the average recovery is 100.2% and the RSD is 0.50%.C onclusion The method is convenient,sensitive and accurate for the determination of the drug.
Keywords:Adefovir Dipivoxil Oxalic Acid tablets  Dissolution  HPLC method
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