高效液相色谱-梯度洗脱法测定恩替卡韦分散片的含量和有关物质

Content Determination of Entecavir Dispersible Tablets and Its Related Substances by Gradient Elution

目的建立测定恩替卡韦分散片含量及其有关物质的高效液相色谱-梯度洗脱法。方法色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相以乙腈-水梯度洗脱,检测波长为254 nm,流速为1 mL/min,柱温为30℃,进样量为20μL。结果恩替卡韦进样量线性范围为1.001～6.006μg(r=0.999 5),平均回收率为100.00%(RSD=0.05%)。结论该方法简便、准确、专属性强,可用于该制剂的质量控制。

Objective To establish a method for the determination of Entecavir Di spersible Tablets and its related substances.Methods HPLC-gradient elution was performed on Kromasil C18 column（250 mm×4.6 mm,5 μm） using acetonitrile-wate r as the mobile phase at a flow rate of 1 mL/min.The detection wavelength was at 254 nm.The column temperature was 30 ℃and the sample size was 20 μL.Results The linear range of entecavir was 1.001-6.006 μg（r=0.999 5）,the average recov ery was 100.00%（RSD=0.05%）.Conclusion The method is simple,accurate,special and can be used for the quality control of Entecavir Dispersible Tablets.