安立生坦片的体外溶出度测定

The method of in vitro dissolution of ambrisentan tablets

目的研究安立生坦片的体外溶出度测定方法。方法采用溶出度浆法,以p H5. 0醋酸盐缓冲液为溶出介质,转速50 r·min^(-1),高效液相色谱法测定,以磷酸二氢钾缓冲液-乙腈(体积比为50∶50)为流动相,色谱柱:Waters Symmetry Shield RP18(150 mm×3. 9 mm,5μm),检测波长:220 nm,柱温:40℃,流速:0. 9×10-3L·min^(-1)。结果安立生坦质量浓度在0. 56~11. 2×10-3g·L^(-1)内线性关系良好,相关系数r=0. 999 6;平均回收率(n=9)为102. 04%,RSD为0. 911%;无滤膜吸附、精密度及重现性良好。测定3批样品的溶出行为,30 min时溶出度均在85%以上。结论该方法可用于本品的溶出度检查。

Objective To establish determination method for the dissolution of ambrisentan tablets in vitro.Methods The pH5. 0 acetate buffer was used as the dissolution medium using paddle method with the rotate speed of 50 r·min-1. The result was determined by HPLC with Symmetry shields RP18（ 150 mm × 3. 9 mm,5 μm microns,Waters） and potassium dihydrogen phosphate buffer-acetonitrile（ 50 ∶ 50） as a mobile phase with the flowrate of 0. 9 mL·min-1. The wavelength was 220 nm and the column temperature was 40 ℃.Results The concentration of ambrisentan was linear in the range of 0. 56-11. 2 mg·L-1 and linear relationship was evaluated as y = 221. 55 x-25. 356（ r = 0. 999 6）. The average recovery rate of ambrisentan（ n = 9） was 102. 04% with the RSD of 0. 911%. The dissolution rates of three batches of ambrisentantablets in vitro at 30 min were more than 85%. Conclusion This method is simple,reliable and accurate for the dissolution determination of ambrisentan tablets.