高效液相色谱法测定注射用唑来膦酸的含量及有关物质  

Assay of zoledronic acid for injection and its related substances by HPLC

作　　者：王玲玲[1] 高嵩 宗国军 胡应和[1] 

机构地区：[1]华东师范大学脑功能基因组学研究所,上海200062 [2]合肥信风科技开发有限公司,合肥230022

出　　处：《中国新药杂志》2006年第8期624-626,共3页Chinese Journal of New Drugs

摘　　要：目的:建立了测定注射用唑来膦酸的含量及有关物质的反相高效液相色谱法。方法:采用C18柱(250 mm×4．6 mm,5μm),以乙腈-四氢呋喃-0．05 mol·L-1磷酸氢二铵(4:1:100,磷酸调节pH值2．55)为流动相用于含量测定,以0．03％氢氧化四丁基铵水溶液(磷酸调节pH值2．55)-乙腈(100:7)为流动相用于有关物质测定。流速1．0 mL·min-1,UV检测波长218 nm。结果:含量测定条件下注射用唑来膦酸在5～125μg·mL-1范围内呈良好的线性关系(r=0．999 9),平均回收率100．3％,RSD=0．50％,有关物质测定条件下,各有关物质与主药的分离良好。结论:本法测定注射用唑来膦酸的含量及有关物质准确可靠。Objective：To establish a HPLC method for assay of zoledronic acid for injection and its related substances. Methods： The reversed-phase HPLC condition was as follows： a C18 ODS column （250 mm × 4.6 mm ,5μm） , an eluate consisted of acetonitrile-tetrahydrofuran-0, 05 mol·L^-1 ammonium dihydrogen phosphate （4： 1： 100, pH = 2.55 adjusted with phosphoric acid） for zoledronic acid assay, an eluate composed of 0.03% tetrabutyl-ammonium hydroxide solution （pH =2.55 adjusted with phosphoric acid）-acetonitrile （100： 7） for the related substances, a flow rate of 1.0 mL·min^-1 and the detection at 218 nm. Results： The calibrated linear curve of zoledronic acid was within 5 - 125μg· mL^-1 The average recovery rate was 100.3% with RSD of 0.50%. The related substances of zoledronic acid were completely separated from zoledronic acid. Conclusion：This reliable RP-HPLC method can be used in quality control of zoledronic acid.

关 键 词：唑来膦酸 反相离子对色谱法 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]