瑞舒伐他汀钙片含量测定方法研究

Study on Determination Method of Rosuvastatin Calcium Tablets

建立瑞舒伐他汀钙片的HPLC含量测定方法。采用Waters CORTECS C18(50×4.6 mm,2.7μm)色谱柱;流动相A为0.01 mol·L^-1乙酸铵溶液(用三氟乙酸调pH值至3.5),乙腈为流动相B,进行梯度洗脱;流速:0.6 mL·min^-1;检测波长为242 nm;柱温为40℃;进样体积10μL。瑞舒伐他汀钙在30~70μg·mL^-1范围内线性关系良好,相关系数r为0.9997;平均回收率为99.59%,RSD为1.23%。该方法操作简便、准确、快捷,可用于瑞舒伐他汀钙片的含量测定。

A HPLC method was developed for the determination of rosuvastatin calcium tablets.The sample was chromatographed on a Waters CORTECS C18 column eluting with acetonitrile and water containing 0.01 mol·L^-1 ammonium acetate(trifluoroacetic acid adjusted pH to 3.5)gradient at the flow rate of 0.6 mL·min^-1.The detection wavelength was at 242 nm,column temperature was at 40℃,and injection volume was 10μL.The linearity of rosuvastatin calcium was good within the range of 30~70μg·mL^-1(r=0.9997).The average recovery rate was 99.59%(RSD=1.23%).The method is simple,accurate,convenient and fast for determination of the tablet of rosuvastatin calcium.