依折麦布辛伐他汀片溶出度的HPLC法测定

Determination of the Dissolution of Ezetimibe/Simvastatin Tablets by HPLC

建立了高效液相色谱法测定依折麦布辛伐他汀片的溶出度。采用Inertsil ODS-3 色谱柱，以25 mmol/L 磷酸二氢钠溶液（ 用10％磷酸调至pH 4.0）- 乙腈（49 ∶ 51） 为流动相，检测波长231 nm。依折麦布和辛伐他汀在1.0 ～ 12.0 μg/ml和2.0 ～ 24.0 μg/ml 浓度范围内线性关系良好；平均回收率为100.8％和100.5％，RSD 为1.0％和1.2％。3 批样品20 min内依折麦布和辛伐他汀的溶出度分别为101.5％、100.2％、101.9％和92.5％、90.9％、91.5％。

An HPLC method was established for the determination of the dissolution of ezetimibe/simvastatin tablets. An ODS-3 column was used, with the mobile phase of 25 mmol/L sodium dihydrogen phosphate solution （adjusted to pH 4.0 with 10% phosphoric acid）-acetonitrile （49︰51）, at the detection wavelength of 231 nm. The calibration curves for ezetimibe and simvastatin were linear in the ranges of 1.0 - 12.0 μg/ml and 2.0 - 24.0 μg/ml. Their average recoveries were 100.8% and 100.5%, with RSDs of 1.0% and 1.2%. The ezetimibe dissolution at 20 min of three batches of samples were 101.5%, 100.2% and 101.9%, while that of simvastatin were 92.5%, 90.9% and 91.5%.