HPLC法测定苹果酸舒尼替尼胶囊中主药的含量  

Content Determination of Main Component in Sunitinib Malate Capsules by HPLC

作　　者：冯亚宁 周会芹 

机构地区：[1]南京华东医药有限责任公司,南京210016 [2]盐城市药品检验所,江苏盐城224002

出　　处：《中国药房》2012年第41期3910-3911,共2页China Pharmacy

摘　　要：目的:建立测定苹果酸舒尼替尼胶囊中主药含量的方法。方法:采用高效液相色谱法。色谱柱为Shimadzu C18,流动相为醋酸铵缓冲液(pH6.8)-乙腈(55:45),流速为1.0mL·min-1,检测波长为430nm,柱温为35℃。结果:苹果酸舒尼替尼检测浓度线性范围为5～25μg·mL-1(r=0.9997),平均回收率为99.65%,RSD=0.66%(n=9)。结论:该方法操作简便、准确性好、精密度高,可作为本品含量测定的方法。OBJECTIVE： To establish a method for the content determination of main component in Sunitinib malate capsules. METHODS： HPLC method was adopted. Shimadzu C18 column was used with mobile phase consisted of ammonium acetate buffer （pH 6.8）-acetonitrile （55：45） at the flow rate of 1.0 mL.min-1. The detection wavelength was set at 430 nm and column tempera- ture was 35 ℃. RESULTS： The linear range of sunitinib malate was 5-25 μg.mL-1 （r=0.999 7） with an average recovery of 99.65% （RSD=0.66%, n=9）. CONCLUSION： The method is simple, accurate and precise, and it is applicable for the determi- nation of Sunitinib malate capsules.

关 键 词：苹果酸舒尼替尼胶囊 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学] R979.1