反相离子对高效液相色谱法测定二甲双胍格列吡嗪片中2种成分含量

Determination of two components in metformin and glipizide tablets by reversed-phase ion-pair HPLC

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。

AIM To establish an reversed-phase ion-pair（RP ion-pair） HPLC method for the determination of contents of metformin and glipizide in metformin and glipizide tablets.METHODS A Kromasil C18 column（4.6 mm × 250 mm,5 μm） was adopted with methanol-3 mmol.L-1 sodium dodecylsulphate（including 0.1% triethylamine and 0.1% glacial acetic acid）（67 ∶ 33,V/V）（pH 4.0） as the flow phase with the flow rate of 1.0 mL.min-1,column temperature at 35 ℃ and detector at λ = 225 nm.RESULTS The calibration curves of metformin and glipizide was linear in the ranges 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）,respectively.The average recovery rates（n = 9） of metformin and glipizide were 99.2% and 98.7%,respectively.CONCLUSION RP ion-pair HPLC is simple,fast,accurate,and high sensitive to provide evidential quality control for metformin and glipizide tablets.