摘要
目的：建立高效液相色谱法测定阿托伐他汀钙分散片的含量。方法：采用Lichrospher C18（250mm×4.6 mm,5μm）色谱柱,流动相为乙腈-0.02 mol.L-1KH2PO4（60∶40,用磷酸调pH至4.0）,检测波长246 nm,流速1.0 mL.m in-1,进样体积20μL。结果：阿托伐他汀钙在1-400μg.mL-1的范围内呈良好的线性关系,相关系数为r=0.999 9;回收率100.17%,RSD为0.84%。结论：本方法简便、准确、专属性强,可用于阿托伐他汀钙分散片的含量的测定。
Objective： To develop a simple,rapid,precise and accurate isocratic reversed-phase HPLC method for analysis of atorvastatin in dispersible tablets.Methods： Separation was achieved on a Lichrospher C18（250 mm×4.6 mm,5 μm） column using a mobile phase consisting of acetonitrile-0.02 mol·L-1 KH2PO4 buffer（60∶40,pH was adjusted to 4.0 with phosphoric acid） at a flow rate of 1.0 mL·min-1 and UV detection at 246 nm.Results： A good linearity was obtained in the range of 1~400 μg·mL-1（r=0.999 9）.The average recovery was 100.17%,RSD=0.84%.Conclusion： This method has shown good resolution for atorvastatin,main impurities,degradation products and formulation excipients of dispersible tablets.Degradation products do not interfere with the detection of atorvastatin and the assay can thus be considered stability-indicating.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2011年第4期382-384,共3页
Chinese Journal of New Drugs
