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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。
Objective: To establish a method for the determination of cis isomers in glimepiride dropping pills by reversed-phase high performance liquid chromatography. Methods: The octadecylsilane bonded silica gel column (4.6 mm × 250 mm, 5 μm) was used with methanol-acetonitrile-0.05 mol·L-1 ammonium phosphate solution (adjusted to pH 4.0 with phosphoric acid) = (30:40 : 30) as mobile phase; flow rate 0.5ml.min-1; column temperature 25 ℃; detection wavelength 228 nm; injection volume 10μl. Results: The peaks of glimepiride peak and its cis-isomer peak were 1.75.3. The cis-isomers of the samples were 0.034%, 0.029% and 0.027%, respectively. Conclusion: The method is simple, sensitive and specific and can be used for the determination of cis isomers in glimepiride dropping pills.