阿托伐他汀钙片有关物质的HPLC分析法

目的建立阿托伐他汀钙片有关物质的测定方法。方法采用反相HPLC法,测定阿托伐他汀钙片有关物质的含量。采用Syncronis C18色谱柱(250mm×4.6mm,5μm);流动相A为醋酸缓冲液∶乙腈∶四氢呋喃(61∶27∶12),流动相B为醋酸缓冲液∶乙腈∶四氢呋喃(47∶41∶12);流速为1.5mL·min~(-1);检测波长为260nm;柱温为35℃。结果阿托伐他汀钙杂质1、杂质2、杂质3、杂质4、杂质6与阿托伐他汀峰均可达到基线分离;检测限分别为阿托伐他汀2ng,杂质1 2ng、杂质2 2ng、杂质3 2ng、杂质4 2ng、杂质6 1.6ng,且重复性良好,总杂质RSD值为1.87%(n=6)。结论该方法稳定、可靠、专属性强,可用于阿托伐他汀钙片的有关物质检测。

Determination of the related substances in Atorvastatin Calcium Tablets by HPLC

Objective To establish a method for the determination of the related substances in Atorvastatin Calcium Tablets .Methods RP‐HPLC was adopted to determine the content of atorvastatin calcium .The determination was performed on a Syncronis C18 col‐umn(250 mm × 4 .6 mm ,5 μm) with the mobile phase A consisited of acetate buffer‐acetonitrile‐tetrahydrofuran(61∶27∶12) ,and the mobile phase B consisited of acetate buffer‐acetonitrile‐tetrahydrofuran(47∶41∶12) .The flow rate was 1 .5 mL · min-1 ,and the detective wavelength was set at 260 nm .The column temperature was 35 ℃ .Results The impurities 1 ,2 ,3 ,4 ,6 and atorvastatin calcium peaks were baselinely separated .The limit of detection of atorvastatin was 2 ng ,and the limits of impurities 1 ,2 ,3 ,4 and 6 were 2 ,2 ,2 ,2 and 1 .6 ng .The repeatbility performed well ,and the RSD was 1 .87% (n=6) .Conclusion The method is reliable , stable ,and specific ,and it is suitable for the the determination of the related substances in Atorvastatin Calcium Tablets .