二甲双胍格列本脲片中两种成分的离子对HPLC法测定

目的：建立用离子对HPLC法测定二甲双胍格列本脲片（复方盐酸二甲双胍片）中盐酸二甲双胍和格列本脲含量的方法。方法：以地西泮为内标，采用Symmetry C18柱（150mm×4．6mm，5ym），流动相为甲醇～2mmol／L十二烷基磺酸钠溶液（58：42），流速1．0mL／min．检测波长分别为232nm（盐酸二甲双胍）和300nm（格列本脲）。结果：盐酸二甲双胍和格列本脲分别在0．500～16．016μg／mL（r=0．9995）和20．040～120．240μg／mL（r=0．9998）范围内线性关系良好。平均方法回收率分别为（100．14±1．79）%（RSD=0．62％,n=3）和（99．95±1．16）％（RSD=0．56％，n=3）。结论：本方法操作简便，结果准确，重现性好，可用于二甲双胍格列本脲片的质量控制。

Determination of two components in metformin hydrochloride and glibenclamide tablets by ion-pair HPLC method

Objective： To cstablish a HPLC method for determination of the contents of metformin hydrochloride and glibenelamide in compound metformin hydrochloride tablets. Methods： Diazepam was used as the internal standard. A Symmetry C1, column was used with the mobile phase of methanoi-2 mmol/L sodium dodecylsulfonate （SDS） （58：42）. The flow rate was 1.0 mL/min. The detective wavelengths were 232 nm for metformin hydrochloride and 300 nm for glibenclamide, respectively.Results：The calibration curves of metformin hydrochloride and glibenclamide were linear in the ranges of 0. 500-16. 016 μg/mL （r =0.999 5） and 20.040-120. 240 /,g/mL （r=0.999 8）,respectively. The average recovery rates were （100.14± 1. 79） % （RSD=0.62%,n=3） and （99.95±1. 16）%（RSD=0.56%,n=3） for metformin and glibenclamide,respectively. Conclusion： This method is simple,rapid,accurate and suitable for quality control of metformin hydrochloride and glibenclamide tablets.