高效液相色谱法测定盐酸二甲双胍片含量的优化

The Optimization Method for Determination of Metformin Hydrochlovide Tablets by High Performance Liquid Chromatography

目的:优化高效液相色谱法测定盐酸二甲双胍片含量。方法:采用Waters Symmerty■ C18(250 mm×4.6 mm,5μm)色谱柱,以0.005 mol/L磷酸二氢钠与0.01mol/L戊烷磺酸钠混合溶液(磷酸调节pH值3.0)-乙腈(94∶6)为流动相,柱温30℃,流速1.0mL/min,进样量5μL,检测波长233nm。结果:盐酸二甲双胍质量浓度在140.36~421.08μg/mL范围内,线性关系良好(r=1.0000),平均回收率为99.10%,RSD为0.54%(n=9)。结论:本方法简便、快速、准确,可用于盐酸二甲双胍片含量的测定。

Objective: To establish a high performance liquid chromatograph(HPLC) method for determining the content of metformin hydrochloride.Methods:The analytical column was Waters Symmerty■ C18(250 mm ×4.6 mm,5μm)and the mobile phase containing 0.005 mol/L sodium dihydrogen phosphate and 0.01 mol/L sodium pentane sulfonate solution(pH 3.0)-acetonitrile(94∶6) at the flow rate of 1.0 mL/min,The column temperature was 30℃ and the sample quantity was 5μL,The UV detection wavelength was at 233 nm.Results: The mass con-centration of metformin hydrochloride in the range of 140.36μg/mL ~421.08μg/mL showed good linear relation with the peak area( r=1.000),the mean recovery was 99.1%( n = 9),RSD= 0.54%.Conclusion:The content determination method for the metformin hydrochloride is convenient,fast,and reproducible.It can be used for the content determination of metformin hydrochloride tablets.