HPLC测定格列美脲顺式异构体的方法改进  

Improvement of determination of cis-isomer in glimepiride by HPLC

作　　者：牛冲[1] 张冬梅[1] 程琳[2] 

机构地区：[1]山东省食品药品检验所,济南250101 [2]山东省卫生教育培训中心,济南250014

出　　处：《药物分析杂志》2013年第1期150-153,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:改进并建立测定格列美脲顺式异构体的高效液相色谱法。方法:采用二醇基硅胶色谱柱(250 mm×4.6 mm,5μm),以冰醋酸-正庚烷-无水乙醇(1∶900∶100)为流动相,流速1.0 mL·min-1,检测波长为228 nm。结果:在上述色谱条件下,格列美脲与顺式异构体分离度良好,顺式异构体的定量限为8 ng,在0.001～0.01 mg·mL-1范围内线性关系良好(r=0.9999)。顺式异构体相对于格列美脲的相对保留时间为0.9,校正因子为1.0。结论:可用不加校正因子的主成分自身对照法测定格列美脲中顺式异构体的含量。Objective：To improve and establish a method for determining cis -isomer in glimepiride by HPLC. Methods：The determination was performed on a diol silica gel column （250mm×4.6mm,5μm） , and the mobile phase consisted of acetic acid - heptane - anhydrous ethanol（ 1： 900： 100） at the flow rate of 1.0 mL . min-1. The detection wavelength was 228 nm. Results： An excellent separation was achieved for glimepiride and its cis - isomer under the above column conditions. The LOQ was 8 ng for cis - isomer, a good linearity was found in the range of 0. 001 -0. 01 mg. mL-1 （r = 0. 9999）. The relative retention time between cis - isome and glimepiride was 0. 9 with a correction factor of 1.0. Conclusion： The method is suitable for the determination of cis - isomer in glimepiride as the self- calibration method for main component without adopting calibration factor.

关 键 词：格列美脲 抗糖尿病药 异构体 有关物质 杂质 高效液相色谱 方法改进 

分 类 号：R917[医药卫生—药物分析学]