论文部分内容阅读
目的建立反相离子对高效液相色谱法同时测定二甲双胍格列吡嗪片中二甲双胍和格列吡嗪的含量。方法采用Kromasil C18柱(4.6 mm×250 mm,5μm),以甲醇-3 mmol.L-1十二烷基磺酸钠(含0.1%三乙胺,0.1%冰乙酸)(67∶33,V/V)(pH 4.0)为流动相,流速为1.0 mL.min-1;检测波长为225 nm;柱温35℃。结果二甲双胍和格列吡嗪浓度分别在31.25～312.5 mg.L-1(r=0.999 4)和0.312 5～3.125 mg.L-1(r=0.999 6)的范围内呈良好的线性关系,平均回收率(n=9)分别为99.2%和98.7%。结论本法准确、快速、灵敏度高,为二甲双胍格列吡嗪片的质量控制提供依据。
Objective To establish a reversed-phase ion pair high performance liquid chromatographic method for the simultaneous determination of metformin and glipizide in metformin glipizide tablets. Methods A Kromasil C18 column (4.6 mm × 250 mm, 5 μm) was used with methanol-3 mmol·L -1 sodium dodecyl sulfate (containing 0.1% triethylamine and 0.1% glacial acetic acid) (67:33, V / V) (pH 4.0) as the mobile phase at a flow rate of 1.0 mL.min-1; detection wavelength was 225 nm; column temperature was 35 ℃. Results The concentrations of metformin and glipizide were linear in the range of 31.25 ~ 312.5 mg.L-1 (r = 0.999 4) and 0.312 5 ~ 3.125 mg.L-1 (r = 0.999 6) The recoveries (n = 9) were 99.2% and 98.7%, respectively. Conclusion This method is accurate, rapid and sensitive, providing the basis for the quality control of metformin glipizide tablets.