HPLC测定二维芦丁片复方制剂中芦丁的溶出度和含量

Determination of Dissolution and Content of Two-dimensional Rutin Tables by HPLC

目的建立HPLC测定二维芦丁片中芦丁溶出度和含量的方法。方法溶出度测定以水(含0.5%SDS)为溶出介质,浆法,转速为75 r·min^(-1),45 min取样,取样后采用HPLC测定;含量测定采用Thermo C_(18)柱(4.6 mm×250 mm,5μm),以磷酸盐缓冲液(0.l mol·L^(-1)磷酸二氢钠溶液,用磷酸调节pH值至4.4)-乙腈(80∶20)为流动相,检测波长为254 nm。结果芦丁在2.26~22.56μg·m^(-1)内与峰面积线性关系良好(r=1.000 0),平均回收率为98.2%(RSD=0.4%),溶出液稳定。3批样品在45 min时平均溶出度均>75%,并且有较好的均一性;含量测定线性关系良好,芦丁回收率为100.6%(RSD=0.4%,n=9)。结论该法简单、准确、重复性好,可用于二维芦丁片中芦丁的溶出度及含量的测定。

OBJECTIVE To determine dissolution and content of rutin in Two-dimensional Rutin tablets by HPLC.METHODS The dissolution medium of determination of dissolution was water（containing 0.5% SDS）.Apparatus 2 was used with 75 r·min^（-1）.The dissiution medium was taken and analyzed by HPLC at 45 min.Determination of content was measured using a Thermo C_（18） column.The mobile phase was treated with phosphate buffer（0.l mol·L^（-1） sodium dihydrogen phosphate solution and adjusted to pH 4.4 with phosphoric acid）-acetonitrile（80∶20）.The detection wavelength was 254 nm.RESULTS Dissolution determination： it showed that stardard curve was linear in the range of 2.26-22.56 μg·m L^（-1）（r=1.000 0）.The average recovery was 98.2%（RSD=0.4%） for rutin.The disslution of Two-dimensional Rutin tablets from three batches were 75%.Determination of content： the method for determination of rutin had a good linearity,and the recovery was 100.6%（RSD=0.4%,n=9）.CONCLUSION The method is simple,sensitive and reproducible,and it can be used for the determination of dissolution and content of Two-dimensional Rutin tablets.