注射用盐酸地尔硫的HPLC测定  

Determination of Diltiazem Hydrochloride for Injection by HPLC

作　　者：王璐璐[1] 郑稳生[1] 谭小川[1] 张宇佳 

机构地区：[1]中国医学科学院协和医科大学药物研究所,北京100050

出　　处：《中国医药工业杂志》2003年第4期180-182,共3页Chinese Journal of Pharmaceuticals

摘　　要：采用 HPL C法测定注射用盐酸地尔硫的含量及有关物质。色谱柱为 Diamonsil C1 8( 15 0 mm× 4.6 m m,5μm ) ,0 .1m ol/ L醋酸钠缓冲液 ( p H6 .2 ) -甲醇 -乙腈 ( 5∶ 6∶ 6 )为流动相 ,检测波长为 2 40 nm。检测限为 0 .2 ng,线性范围为 6～ 14μg/ ml( r=0 .9998) ,RSD为 0 .11% ,平均回收率为 10 0 .2 % ,RSD为 0 .5 2 %。A HPLC method for the determination of diltiazem hydrochloride for injection and its related substances was presented. Diamonsil C18 column was used, with mobile phase of 0.1 mol/L sodium acetate buffer solution (pH6.2)-methanol-acetonitrile (5∶6∶6) and at detection wavelength of 236 nm. The detection limit was 0.2 ng. The linear range was 6～14 μg/ml, and average recovery was 100.2% with RSD of 0.52%.

关 键 词：注射用 盐酸地尔硫ZHUO 有关物质 HPLC 测定 

分 类 号：R972[医药卫生—药品] R927.2[医药卫生—药学]