反相高效液相色谱法测定格列美脲滴丸中顺式异构体

目的:建立反相高效液相色谱法测定格列美脲滴丸中顺式异构体的方法。方法:采用十八烷基硅烷键合硅胶色谱柱(4.6 mm×250 mm,5μm),以甲醇-乙腈-0.05 mol.L-1磷酸铵溶液(用磷酸调pH至4.0)=(30∶40∶30)为流动相;流速0.5ml.min-1;柱温25℃;检测波长为228 nm;进样量为10μl。结果:格列美脲峰与其顺式异构体峰分离度为1.75。3批样品中顺式异构体分别为0.034%,0.029%,0.027%,均符合规定。结论:本方法简便、灵敏、专属性强,可用于格列美脲滴丸中顺式异构体的检查。

Determination of the Cis isomer in Glimepiride Pills by RP HPLC

Objective： To establish an HPLC method for the determination of the cis-isomer in glimepiride pills. Method： The HPLC system consisted of a C）s column （4.6 mm × 250 mm, 5μm） and methanol- aeetonitrile-0.05 mol · L-1 ammonium phosphate （adjusting pH to 4.0 with phosphoric acid）（30： 40： 30）as the mobile phase. The flow rate was 0.5 ml min-1 ,the detection wavelength was set at 228 nm with the temperature of 25℃ and the sample volume was 10μl. Result： The resolution of glimepiride and cis- isomer was 1.75. The cis-isomer in 3 batches of glimepiride pills was 0.034%, 0.029% and 0.027%, respectively. Conclusion： The method is simple,sensitive and specific. It is suitable for the determination of the cis-isomer in glimepiride pills.