HPLC法测定盐酸消旋山莨菪碱注射液中主药的含量  

Content Determination of Main Components in Racanisodamine Hydrochloride Injection by HPLC

作　　者：丁燕 修虹[2] 

机构地区：[1]宁夏回族自治区固原市药品检验所,固原市756000 [2]福建省药品检验所,福州市350001

出　　处：《中国药房》2009年第7期540-541,共2页China Pharmacy

摘　　要：目的:建立以高效液相色谱法测定盐酸消旋山莨菪碱注射液中主药含量的方法。方法:色谱柱为Phenomenex Luna C18,流动相为甲醇-0.02%三乙胺(50∶50),流速为1.0mL·min-1,检测波长为220nm,进样量为20μL,柱温为室温。结果:消旋山莨菪碱检测浓度的线性范围为0.053～0.371μg·mL-1(r=0.999 9);平均回收率为101.20%,RSD=0.23%(n=6)。结论:本方法操作简便、快速、结果准确,可用于该制剂的质量控制。OBJECTIVE： To establish an HPLC method for the determination of the content of main components in racanisodamine hydrochloride（RH） injection. METHODS： The determination was performed on Phenomenex Luna C18 column with methanol 0.02% triethylamine （50 ： 50） used as mobile phase at a flow rate of 1.0 mL · min ^-1. The detecting wavelength was set at 220 nm; the column temperature was set at room temperature and the sample size was 20μL. RESULTS： The linear range ofRHwas0.053--0.371μg·mL^-1 （r=0.9999） and the average recover was 101.20% （RSD=0.23%, n = 6） . CONCLUSIONS： The method is proved to be simple, rapid, accurate and applicable for the determination of the content of RH in RH injection.

关 键 词：盐酸消旋山莨菪碱 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学] R971.92