HPLC法测定恩替卡韦片的溶出度

为建立HPLC法测定恩替卡韦片溶出度的方法。以0.05mol·L-1磷酸二氢钾溶液(用1mol·L-1的氢氧化钠溶液调节pH值为6.8)1000mL为溶出介质,转速为50r/min,取样时间30min,采用桨法测定恩替卡韦片的溶出度。结果表明恩替卡韦在0.25~0.61μg·mL-1范围内线性关系良好(R=0.9996),平均回收率为100.1%,RSD=0.29%(n=9)。该方法操作简便,结果准确可靠,辅料对溶出度测定无影响,可用于该制剂的质量控制。

Determination of Dissolution Rate of Entecavir Tablets by HPLC

Objective To establish an HPLC method for detecting dissolution of entecavir tablets. Methods 0. 05mol/L potassium dihydrogen phosphate solution （ 1mol · L^-1 sodium hydroxide solution pH adjusted to 6.8） 1000ml were used as dissolution medimns, the rotating speed of 50 r · min ^- 1, and the sampling time was 30 minute. The dissolution of enteeavir tablets was detemfined by oar method. Results Enteeavir showed a good linear relationship with in the range of 0.25 ~ 0. 61μg · mL^-1（r = 0. 9996） and the average recovery was 100.1%, with RSD of 0.29% （n = 9）. The mean cumulative dissolution of three batches of entecavir tablets was above 90%. Conclusion The method is simple, accurate, can eliminate the influence of excipients, and can be used in quality control.