【作者】 王璐璐; 郑稳生; 谭小川; 张宇佳;
【Author】 WANG Lu-Lu, ZHENG Wen-Sheng, TAN Xiao-Chuan, ZHANG Yu-Jia (Chinese Academy of Medical Sciences, Institute of Materia Medica, Beijing 100050)
【机构】 中国医学科学院协和医科大学药物研究所; 中国医学科学院协和医科大学药物研究所 北京100050; 北京100050; 北京100050;
【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 %。 更多还原
【Abstract】 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%. 更多还原
【关键词】 注射用盐酸地尔硫; 有关物质; HPLC; 测定;
【Key words】 diltiazem hydrochloride for injection; related substance; HPLC; determination;