反相高效液相色谱法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 RP-HPLC

目的建立盐酸二甲双胍肠溶片含量测定的反相高效液相色谱法。方法采用C18(4.6mm×150mm,5μm)色谱柱;流动相:0.05mol·L-1磷酸二氢钾(用磷酸调pH值至3.5,含0.03%十二烷基硫酸钠)-甲醇(55:45);流速:1.0mL·min-1;柱温:30℃;检测波长:232nm。结果盐酸二甲双胍在4～80μg·mL-1范围内线性关系良好,r=1.0000,平均回收率为99.7%(n=9)。结论 HPLC方法简便,准确,可靠,可作为盐酸二甲双胍肠溶片的质量控制方法。

OBJECTIVE To establish an HPLC method for determination of Metformin Hydrochloride in Metformin Hydrochloride Enteric-Coated Tablets.METHODS C18 column（4.6mm×150mm,5μm）was used;The mobile phase was 0.05mol ·L-1 sodium dihydrogen phosphate（adjusted to pH 3.5 with phosphoric acid,containing 0.03% sodium laurylsulfate）-methano（55∶45）;Then detected at 232 nm with a flow rate of 1.0mL·min-1 and the column temperature was 30℃.RESULTS The standard curves for Metformin Hydrochloride were linear over the range of 4～80μg·mL-1,r=1.0000,with the average recovery was 98.6%（n=9）.CONCLUSION The method is simple,reliable and accurate.It can be applied in quantitative determination of Metformin Hydrochloride Enteric-Coated Tablets.