摘要
目的建立恩替卡韦分散片溶出度的HPLC测定方法。方法以0.05 mol/L磷酸二氢钾溶液250 ml为溶出介质,转速为50 r/min,取样时间为45 min,采用桨法测定恩替卡韦分散片的溶出度。结果恩替卡韦检测浓度的线性范围为0.5～10μg/ml(r=0.9999);方法专属性和精密度良好;平均回收率为99.91%,RSD为0.04%;3批样品45 min平均溶出度均在90%以上。结论该法操作简便,结果准确可靠,可用于恩替卡韦分散片的溶出度测定。
Objective To establish an HPLC method for the determination of dissolution of entecavir dispersible tablets.Methods 250 ml 0.05 mol/L potassium dihydrogen phosphate was taken as the solvent at the rotating speed of 50 r/min,and the sampling time was 45 min.The dissolution of entecavir dispersible tablets was determined by oar method.Results The linear range of entecavir was 0.5-10.0 μg /ml（r=0.9999）,with an average recovery rate of 99.91%.RSD was 0.04%.The mean cumulative dissolution of three batches of entecavir dispersible tablets was above 90%.Conclusion The established method is simple,accurate and reliable for the determination of dissolution of entecavir dispersible tablets.
出处
《解放军药学学报》
CAS
2012年第1期60-62,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
