降血糖新药格列美脲的HPLC含量测定法

HPLC determination of a new antidiabetic drug: glimepiride.

采用ZORBAX—C18色谱柱(4.6 mm×150 mm,5μm),以甲醇-0.03 mol/L磷酸二氢胺水溶液(70:30,用磷酸调节缓冲盐水溶液的pH为3.5)作为流动相,流速1.0 mL/min;紫外检测波长为230 nm.用安定做为内标测定格列美脲(glimepiride,GMD)原药的含量.此方法对格列美脲的线性范围是10μg/mL～200 μg/mL,相关系数r>0.999 9;最低检测限为1.2 ng;平均回收率为99.39％～100.34％.RSD是0.33％～0.37％.结果表明用反相HPLC测定格列美脲原药含量操作简便,结果准确.

A simple HPLC method was established for quantitative determination of glimepiride (GMD). The chro-matographic column is a ZORBAX-C18 column. The mobile phase is a methanol-phosphate solution (70 : 30) with diazepam as internal standard. The elution was performed at a flow rate of 1. 0 mL/min. The detection wavelength was set at 230nm. The calibration curve is linear in the rage of 10 u/mL to 200 ug/mL and the correlation coefficient is greater than 0. 999 9. The average recovery is in the range of 99. 39% to 100% and RSD is in the range of 0. 33% to 0. 37%. The lowest detection limit is 1. 2 ng/mL. The method is fast, accurate and simple.