RP-HPLC法测定大鼠血浆中阿仑膦酸钠药物浓度  

RP-HPLC determination of alendronate sodium in rats plasma

作　　者：刘广兴[1] 卢婷利[1] 桑澎[1] 齐亚峰 梅其炳[1,2] 

机构地区：[1]西北工业大学生命科学院空间生物实验模拟技术国防重点学科实验室,西安710072 [2]西安市新药评价研究中心,西安710065

出　　处：《药物分析杂志》2008年第12期2118-2121,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立阿仑膦酸钠体内分析方法。方法:利用二乙基胺(EDA)SPE 柱提取纯化药物,以9-芴基甲基氯甲酚酯为荧光衍生剂对阿仑膦酸钠进行柱前衍生,Waters X-Terra RP C_(18)色谱柱(150 mm×4.6 mm,5μm),甲醇-缓冲液(含25 mmol·L^(-1)柠檬酸和25 mmol·L^(-1)焦磷酸钠)-乙腈-水为流动相,梯度洗脱;流速:1.0 mL·min^(-1);柱温:35℃;荧光检测器激发波长260 nm,发射波长310 nm。结果:该方法线性范围为1～100 ng·mL^(-1),线性关系良好(r^2=0.9996);方法回收率、日内和日间精密度的 RSD 均小于15%。结论:该分析方法可行性较高,重现性好,可用于阿仑膦酸钠药物代谢动力学研究。Objective：To establish a method for analyzing alendronate sodium in vivo. Method：An HPLC method was developed using diethylamine （DEA） solid -phase for extraction （SPE）, and 9 -fluorenyhnethyl derivative （Fmoc） for pre- column derivation. Liquid chromatography was performed on a Waters X- Terra RP C18 column （150 mm ×4. 6 ram,5 μm） ,using a gradient method for mobile phase of methanol -buffer （25 mmol· L-1citric acid,25 mmol· L- 1 pyrophosphate sodium） acetonitrile -water. The flow -rate was 1.0 mL · nin-1 at 35 ℃. The excitation and emission wavelengths of fluorescence detection were 260 and 310 nm, respectively. Result：The cali- bration curves were linear in the range of 1 - 100 ng · mL- 1, and it has fine linear correlation （ correlation coeffi- cient, r = 0. 9996）. The recovery rate of the method, and the intra - and inter - day precisions expressed as the rela- tive standard deviation were less than 15% respectively. Conclusion：The method is demonstrated to be highly feasi- ble and reproducible for pharmacokinetic studies of alendronate sodium.

关 键 词：阿仑膦酸钠 9-芴基甲基氯甲酚酯 衍生 荧光检测器 

分 类 号：R917[医药卫生—药物分析学]