高效液相色谱法测定消渴灵片中格列本脲含量

目的 建立测定消渴灵片中格列本脲含量的高效液相色谱法（HPLC法）。方法Dionex Kromasil ODSl色谱柱（250mm×4．6mm，5μm），流动相为甲醇-0．02mol／L磷酸溶液（65：35，合十二烷基硫酸钠0．03％，用三乙胺调节pH值至3．5），流速为1．50mL／min，检测波长为230nm，进样量为20μL。结果 格列本脲进样量在0．57—5．68μg范围内与峰面积线性关系良好（r=0．9999，n=5），平均回收率为101．0％，RSD为0．24％（n=6），重复进样RSD为0．18％（n=5），检测限为0．2ng（S／N=3）。结论 HPLC法简便、快速、灵敏，适用于格列本脲的含量测定。

Determination of Glibenclamide in Xiaokeling Tablets by HPLC

Objective To develop the HPLC method for the determination of glibenclamide in Xiaokeling tablets. Methods Chromatography was performed on a column of Dionex Kromasil ODS1 （250mm×4.6mm,5μm） with a mixture of methanol and 0.02 mol/L phosphoric acid （65 ： 35, containing 0.03% sodium laurylsulfate, adjusting triethylamine to pH = 3.5） as mobile phase. The flow rate was 1.50 mL/min. The detective wavelength was at 230 nm. Results There was a good linear relationship over the range of 0. 57 - 5. 68 μg of glibenclamide. r=0.9999（n=5）.The average recovery rate was 101.0% with RSD was 0.24% （n=6）. RSD of peak areas for repetition was 0. 18%（n=5）. The limits of detection was 0. 2 ng（S/N=3）. Conclusion The method is simple, rapid, accurate and can be used to assay glibenclamide.