RP-HPLC法测定唑来膦酸的含量及其相关物质  

Quantification of zoledronic acid and its relevant substances by RP-HPLC

作　　者：赵怀清[1] 鲁鑫焱[1] 张超[1] 巩克民[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2005年第2期191-194,共4页Chinese Journal of New Drugs

摘　　要：目的:建立测定唑来膦酸的含量和有关物质的RP-HPLC法。方法:采用C_(18)色谱柱(200mm×4.6mm,5μm),流动相为乙腈-8mmol·L^(-1)的焦磷酸钠(含20mmol·L^(-1)四丁基氢氧化铵,磷酸调pH至6.8)(6∶100),流速为1.0mL·min^(-1),检测波长215nm,柱温30℃。结果:唑来膦酸在20～160μg·mL^(-1)范围内线性关系良好,r=0.999 9。加样回收率为100.1%,RSD=0.5%(n=9)。结论:该法操作简便、准确,为唑来膦酸提供了方便可靠的含量测定及其有关物质的检测方法。Objective: To establish a RP-HPLC procedure for quantification of zoledronic acid and its relevant substances. Methods: The optimal chromatography was performed with a C_(18) column (200mm×4.6mm, 5μm), the column temperature at 30℃, acetonitrile-8mmol·L^(-1) sodium pyrophosphate decahydrate solution(6∶100) composed of 20mmol·L^(-1) TBAOH (pH adjusted to 6.8 with phosphoric acid) as a mobile phase, flow rate at 1.0mL·min-1, and UV detection at 215nm. Results: The calibrated linear plot of zoledronic acid concentrations was within 20～160μg·mL^(-1)(r=0.999 9). The mean recovery rate was 100.1% with RSD of 0.5% (n=9). Conclusion: The easy and accurate chromatography is reliable in the quantification of zoledronic acid and its relevant substances.

关 键 词：唑来膦酸 反相离子对高效液相色谱法 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学] R977.24