摘要
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 extendC18(4.6 mm×250 mm,5μm);流动相:0.05 M磷酸二氢钠缓冲液(用磷酸调p H至2.0):乙腈:甲醇=46:20:34;检测波长:242 nm;流速:0.7 m L·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%。
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.
出处
《中国药物警戒》
2014年第11期657-660,663,共5页
Chinese Journal of Pharmacovigilance
