高效液相法测定依折麦布片的含量

Determination of Ezetimibe in Ezetimibe Tablets by HPLC

建立了依折麦布片含量测定方法。采用高效液相色谱法测定依折麦布的含量。色谱柱为C18(5μm,4.6 mm×250 mm),流动相为乙腈-0.05%庚烷磺酸钠水溶液(65∶35),检测波长232 nm,流速1.0 mL/min。结果表明:依折麦布浓度在2～20μg/mL范围内,峰面积与浓度线性关系良好,平均回收率为99.4%(RSD=0.53%)。结果该法简便、准确、灵敏度高重现性好,可用于依折麦布的含量测定。

The HPLC method for determination of Ezetimibe in Ezetimibe tablets was established. The assay involved an isocratic elution of ezetimibe in a Cls column（5μm,4.6 mm×250 mm） , using a mobile phase composition of acetonitrile and 0.05% sodium heptanesulfonate（65 ： 35 ）. The determination wavelength was 232 nm and the flow rate was 1.0 mL/min. The result showed ezetimibe had a linear range of 2 - 20 μg/mL with a mean recovery of 99.4% （ RSD = 0.53% ）. The method was convenient, accurate, and sensitive. It can be used for the determination of ezetimibe.