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。
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.
出处
《中外医疗》
2013年第17期18-19,共2页
China & Foreign Medical Treatment
