不同厂家唑来膦酸制剂的含量考察  

Determination of Content of Zoledronic Acid from Different Factories

作　　者：陈倩超[1] 黄红兵[1] 曾昭蕾[1] 

机构地区：[1]华南肿瘤学国家重点实验室,中山大学附属肿瘤医院,广州市510060

出　　处：《中国医院用药评价与分析》2008年第11期840-841,共2页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:利用HPLC建立唑来膦酸粉针剂含量的检测方法,并对目前市场上在用的3个厂家的唑来膦酸进行检测,为选择药品及临床使用提供参考。方法:色谱柱:HypersilSax Dim C18柱(250mm×4.6mm,5μm);流动相:乙腈-四氢呋喃-0.05mol·L-1膦酸氢二胺-10%的四丁基氢氧化胺(8∶1∶100∶1),pH调节至2.5;流速1.0mol·min-1;检测波长:210nm;进样量:20μL;柱温:室温。结果:3个厂家的产品含量分别为标示量的96.58%、98.61%、100.63%,RSD分别为1.31%、1.18%、0.93%。结论:3个厂家的唑来膦酸含量差别不大。OBJECTIVE： To establish an HPLC method for the determination of Zoledronic Acid injectable powder and the detection of Zoledronic Acid in use from 3 factories so as to provide reference for the choice of drugs and clinical use. METHODS： The determination was performed on HypersilSax Dim C18 （250 mm× 4.6 mm, 5 μm） with the mobile phase consisted of Acetonitrile - Tetrahydrofuran - 0.05 mol . L^-1 Hydrogen phosphate diamine - 10 % Tetrabutylamminium hydroxide amine （8 ： 1 ： 100 ： 1 ） （pH = 2.5） at a flow rate of 1.0 mol.min^-1. The detection wavelength was set at 210 nm ; the sample size was 20uL and the column temperature was maintained at room temperature. RESULTS： The labeled contents of zoledronic acid from three manufactures stood at 96.58%, 98.61%, and 100.63% respectively with RSD at 1.31%, 1.18%, and 0.93% respectively. CONCLUSION： The contents of zoledronic acid from three factories showed little difference.

关 键 词：唑来膦酸 高效液相 含量 

分 类 号：R965[医药卫生—药理学]