HPLC法测定盐酸兰地洛尔起始物料B中有关物质的含量  

Content Determination of Related Substances in Landiolol Hydrochloride Starting Material B by HPLC

作　　者：曾正渝[1] 曾雪[1] 陈竹[1] 谭韬[1] 

机构地区：[1]重庆医药高等专科学校,重庆400033

出　　处：《中国药房》2013年第45期4294-4295,共2页China Pharmacy

摘　　要：目的:建立测定合成盐酸兰地洛尔起始物料B中有关物质含量的方法。方法:采用高效液相色谱法。色谱柱为Agilent XDB C18,流动相为乙腈-水(40∶60),流速为1.0 ml/min,检测波长为222 nm,柱温为室温。结果:杂质A检测质量浓度线性范围为0.738~6.0μg/m(lr=0.999 9),总平均回收率为100.06%(RSD=0.48%,n=3),检测限和定量限分别为0.038 5、0.13 ng。结论:建立的方法简便、快捷、结果可靠,可用于盐酸兰地洛尔起始物料B的质量控制。OBJECTIVE： To establish the method for the content determination of related substance in landiolol hydrochloride starting material B. METHODS： HPLC method was adopted. The determination was performed on Angilent XDB C^s column with acetonitrile-water （40：60） at the flow rate of 1.0 ml/min. The detection wavelength was set at 222 nm and column temperature was room temperature. RESULTS： The linear range of impurity A were 0.738-6.0 ug/ml （r=0.999 9） with an average recovery of 100.06% （RSD=0.48%, n=3）. The detection limit and detection limit were 0.038 5 ng and 0.13 ng. CONCLUSIONS： The meth- od is simple, rapid and reliable, and suitable for the quality control of landiolol hydrochloride starting material B.

关 键 词：盐酸兰地洛尔 起始物料B 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R972.2