离子交换色谱法测定盐酸二甲双胍片的含量

Determination of Metformin Hydrochloride Tablets by ion exchange chromatography

目的建立离子交换色谱法测定盐酸二甲双胍片中盐酸二甲双胍含量的方法。方法色谱柱:SHISEIDO CAPCELLPAK SCX UG80(250mm×4.6mm,5μm);流动相:0.2mol·L-1磷酸二氢铵溶液-乙腈(80∶20)(用磷酸调节pH值至3.5);流速:1.5mL·min-1;检测波长:233nm;柱温:35℃。结果盐酸二甲双胍进样量在0.103 6～1.036 0μg范围内与峰面积响应值呈良好的线性关系,r=0.999 9;平均回收率为98.9%,RSD为0.9%(n=6)。结论该方法专属性强,结果准确,灵敏度高,重复性好,可作为盐酸二甲双胍片质量控制的方法。

Objective To establish a quantitative method for Metformin Hydrochloride Tablets by ion exchange chromatography.Methods SHISEIDO CAPCELL PAK SCX UG80（250 mm×4.6 mm,5 μm） column was used.The 0.2 mol·L-1 ammonium dihydrogen phosphate solution-acetonitrile（80∶20）（adjusting pH to 3.5 with phosphoric acid） was used as the mobile phase.The flow rate was 1.5 mL·min-1.The detection wavelength was set at 233 nm.Column temperature：35 ℃.Results The linear range of metformin hydrochloride was 0.103 6-1.036 0 μg and the correlation coefficient was 0.999 9.The average recovery rate was 98.9% with RSD 0.9%（n=6）.Conclusion The method is specific,accurate,sensitive and reproducible,which can be used to control the quality of Metformin Hydrochloride Tablets.