高效液相色谱法测定瑞舒伐他汀钙片中8种有关物质的含量

目的：建立瑞舒伐他汀钙片有关物质测定方法；方法制备瑞舒伐他汀钙片中8种杂质，以色谱柱：Agilent extend-C18（4.6 mmx250 mm，5μm）；流动相：0.05 M磷酸二氢钠缓冲液（用磷酸调pH至2.0）：乙腈：甲醇=46：20：34；检测波长：242 nm；流速：0.7 mL·min-1为色谱条件，采用对照品对照法计算瑞舒伐他汀钙片中8种杂质的含量；结果瑞舒伐他汀非对映异构体、5-氧化-瑞舒伐他汀、瑞舒伐他汀-5S-内酯在3批瑞舒伐他汀钙片中含量最高；结论规定瑞舒伐他汀钙片中杂质A、B、C的含量不得过0.5%，杂质D、E、F、G、H不得过0.2%，单杂不得过0.2%，总杂质不得过1.5%。

Determination of Eight Impurities of Rosuvastatin Calcium Tablets by HPLC

Objective To establish the related substance method of rosuvastatin calcium tablets. Methods Prepared eight impurities of rosuvastatin calcium tablets first, Column：Agilent extend-C18 （4.6 mmx250 mm, 5μm） with mobile phase consisted of 0.05 M sodium dihydrogen phosphate buffer （adjusted to pH 2.0 with phosphoric acid）：acetonitrile：methanol=46：20：34 at a flow rate of 0.7 m·min-1 when the detective wavelength was set at 242 nm, used external standard method to calculate the content of impurities. Results The contents of （3S, 5S）-rosuvastatin calcium, 5-oxo-rosuvastatin and rosuvastatin-5S-lactone are more than others in three batches of rosuvastatin calcium tablets. Conclusion The contents of impurity A, B, C should not be more than 0.5% and impurity D, E, F, G, H should not exceed 0.2%, for each unspecified impurities not more than 0.2%and not more than 1.5%for total.