反相高效液相色谱法测定盐酸二甲双胍缓释片的含量

Determination of Metformin Hydrochloride in Metformin Hydrochloride Sustained-release Tablets by RP-HPLC

目的测定盐酸二甲双胍缓释片中盐酸二甲双胍的含量。方法采用反相高效液相色谱(RP-HPLC)法,使用Zorbax Eclipse XDB-C18柱(150mm×4.6mm,5μm),流动相为0.05mol/L磷酸二氢钠(用磷酸调pH值至3.5,含0.001mol/L十二烷基硫酸钠)-甲醇(50∶50),检测波长为232nm。结果盐酸二甲双胍质量浓度在20～80μg/mL范围内与峰面积有良好的线性关系,r=0.9998(n=7),平均加样回收率为100.06%,RSD为0.57%(n=6)。结论RP-HPLC法准确、简单,能够有效控制盐酸二甲双胍缓释片的含量。

Objective To establish a analysis method for metformin hydrochloride in metformin hydrochloride sustained-release tablets. Methods RP-HPLC method was used, The chromatographic conditions were as follows： Zorbax Eclipse XDB-C18 column （150 mm × 4.6 mm,5 μm）;the mobile phase was 0.05 mol/L sodium dihydrogen phosphate （adjusted to pH 3.5 with phosphoric acid,containing 0.001 mol/L sodium laurylsulfate）- methanol （50 ： 50）;the detection wavelength was 232 nm. Results The linear ranges of metformin hydrochloride was 20-80 μg/mL, r was 0. 999 8 （n =7）. The recovery rate was 100.06%, RSD was 0.57% （n =6）. Conclusion This method is accurate and simple. It can be used as the quality control method for metformin hydrochloride sustained-release tablets.