HPLC法测定瑞格列奈片中葡甲胺的含量  

Determination of Meglumine in Repaglinide Tablets by HPLC

作　　者：李建伟[1] 李慧峰 

机构地区：[1]长治医学院药学系,046000 [2]山西振东制药股份有限公司

出　　处：《长治医学院学报》2013年第1期8-11,共4页Journal of Changzhi Medical College

基　　金："十二五"山西省科技重大专项"创新药物研制"项目(20121101013)

摘　　要：目的:建立瑞格列奈片中葡甲胺含量的测定方法。方法:采用HPLC法,以乙腈-磷酸盐缓冲液(5∶95)为流动相,色谱柱为SHISEIDO SPOLAR C18(4.6mm×150mm,5μm),流速为1.0mL/min,柱温为25℃,检测波长为195nm。结果:葡甲胺在0.09957～4.979mg/mL内,与峰面积呈良好线性关系,相关系数为1.0000;平均回收率(n=9)为99.65%(RSD=1.24%)。结论:方法简便、准确、重现性好,可作为测定瑞格列奈片中葡甲胺含量的方法。Objective： To develop a quantitative method for determining the contents of meglumine in Repaglinide Tablets. Methods：The analysis was performed with a SHISEIDO SPOLAR C18（4.6mm×150mm,5μm） column and a mobile phase of acetonitrile-Phosphate buffer solution with isocratic elution. The flow rate was 1.0 mL/min, and column temperature was 25 ℃. The detection wavelength was set at 195 nm. Results： The calibration curve was linear within the range of 0. 09957-4. 979 mg/mL for meglumine （ r =1. 0000）. The average recoveries of the two contents were 99.65% （RSD= 1.24 %）. Conclusion： This method is convenient, accurate and reliable, and can be used as quality control methods for meglumine in Repaglinide Tablets.

关 键 词：瑞格列奈 葡甲胺 高效液相色谱法 含量测定 

分 类 号：R914.1[医药卫生—药物化学]