HPLC测定盐酸二甲双胍肠溶片的含量

Determination of Metformin Hydrochloride in Metformin Hydrochloride Enteric-Coated Tablets by HPLC

建立高效液相色谱法测定盐酸二甲双胍肠溶片含量的方法。采用Hypersil ODS2色谱柱(4.6mm×250mm,5μm),0.05%庚烷磺酸钠溶液(用10%磷酸溶液调节pH值至4.0)∶乙腈(84∶16)为流动相,紫外检测波长233nm;流速1.0mL/min;柱温为30℃。盐酸二甲双胍在0.11—10.70μg/mL浓度范围内峰面积与浓度线性关系良好,线性回归方程为A=94291C(μg/mL)-35840,r=0.9997(n=5),平均回收率为99.22%,RSD为1.79%。本法简便,准确,制剂中辅料无干扰,适合盐酸二甲双胍肠溶片含量的测定。

The method for the determination of metformin hydrochloride in metformin hydrochloride enteric-coated tablets was established by HPLC.Samples were separated on Hypersil ODS2 column（4.6mm×250mm,5μm）with 0.05% heptane-1-sulfonic acid sodium salt solution（pH was adjusted to 4.0 by 10% phosphoric acid）-acetonitrile（84∶16） as the mobile phase at a flow rate of 1.0mL/min.The detection wavelength was 233nm,and the column temperature was 30℃.The linear range of metformin hydrochloride was 0.11—10.70μg/mL（r=0.9997） with an average recovery of 99.22%（RSD=1.79%）.The method is simple,accurate,and materials in the preparation has no interference and suitable for the determination of main content in metformin hydrochloride enteric-coated tablets.