目的 建立同时测定依折麦布瑞舒伐他汀钙复方片(10，5 mg)中依折麦布(EZT)和瑞舒伐他汀钙(ROS)有关物质的方法。 方法 采用反相高效液相色谱法。色谱柱为Kromasil 100-5 C₁₈ Dimensions柱(4.6 mm×150 mm， 5 μm)，以0.05 mol·L^-1磷酸二氢钾(pH 4.0)-乙腈-甲醇(60∶30∶10)为流动相A，以0.05 mol·L^-1磷酸二氢钾(pH 4.0)-乙腈-四氢呋喃(40∶50∶10)为流动相B，进行梯度洗脱。流速为1.0 mL·min^-1，检测波长为242 nm，进样量为20 μL。测定EZT、ROS和ROS杂质1、ROS杂质2、ROS杂质3、EZT杂质1、EZT杂质2、EZT杂质3、EZT杂质4、EZT杂质5、EZT杂质6、EZT杂质7的线性方程，以斜率计算杂质相对于EZT或ROS的校正因子，用相对保留时间确定各杂质位置。结果 ROS杂质1、ROS杂质2、ROS杂质3、ROS杂质4、EZT杂质1、EZT杂质2、EZT杂质3、EZT杂质4、EZT杂质5、EZT杂质6、EZT杂质7的相对保留时间(相对于ROS)分别为1.5，1.9，2.1，1.1，1.7，2.5，2.6，2.8，2.9，3.0，4.0，校正因子分别为1.1，1.1，1.0，1.0，1.3，1.1，1.0，1.3，1.4 ，0.5，1.0。3批样品中ROS杂质4的含量均为0.15％，其他杂质均小于0.1%，总杂质分别为0.27%，0.27%，0.26%。结论 方法简便快速，可准确测定依折麦布瑞舒伐他汀钙复方片中有关物质的含量。

OBJECTIVE To establish the self contrast and correction factor method for the content determination of the related substances in compound ezetimibe and rosuvastatin calcium tablets simultaneously. METHODS RP-HPLC method was adopted. The determination was performed on Kromasil 100-5 C₁₈ Dimensions column (4.6 mm×250 mm, 5 μm) with mobile phase A consisting of methanol-acetonitrile-0.05 mol·L^-1 potassium dihydrogen phosphate (adjusted to pH 4.0 with phosphoric acid) (10∶30∶60) and mobile phase B consisting of tetrahydrofuran-acetonitrile-0.05 mol·L^-1 potassium dihydrogen phosphate (adjusted to pH 4.0 with phosphoric acid) (10∶50∶40) at a flow rate of 1.0 mL·min^-1. The detection wavelength was set at 242 nm. The injection volume was 20 μl. The slope of linear equation was used to determine the correction factors between ROS impurities 1, 2, 3, EZT impurities 1, 2, 3, 4, 5, 6, 7 and ezetimibe or rosuvastatin calcium. The relative retention time was used to determine the positions of impurities. RESULTS The relative retention time of ROS impurities 1, 2, 3, 4 and EZT impurities 1, 2, 3, 4, 5, 6, 7 to rosuvastatin calcium was 1.5, 1.9, 2.1, 1.1, 1.7, 2.5, 2.6, 2.8, 2.9, 3.0, and 4.0, respectively.The correction factors of ROS impurities 1, 2, 3, 4 and EZT impurities 1, 2, 3, 4, 5, 6, 7 were 1.1, 1.1, 1.0, 1.0, 1.3, 1.1, 1.0, 1.3, 1.4, 0.5, and 1.0,respectively.The content of ROS impurity 4 was 0.15% in three batches of samples, the other impurities were less than 0.1%, and the contents of total impurities were 0.27%, 0.27%, and 0.26%, respectively. CONCLUSION The method is simple,efficient, and accurate for analyzing the related substances in compound ezetimibe and rosuvastatin calcium tablets.