HPLC法测定盐酸二甲双胍片的含量和有关物质

Determination of metformin hydrochloride tablets by HPLC

目的建立HPLC法测定盐酸二甲双胍片的含量和有关物质的方法。方法采用依利特Hypersil BDS CN（4．6mm×250mm）色谱柱，甲醇-水（10：90）（含0．003％三乙胺，用0．1mol·L^-1盐酸调节pH=5．4）为流动相，含量测定检测波长232nm，有关物质检测波长215nm。结果盐酸二甲双胍在0．01-0．1mg·L^-1范围内线性关系良好（r=0．99998）；平均回收率为99．9％，RSD为0．84％（n=9）。结论本方法快速、简便、准确，可用于盐酸二甲双胍片的质量控制。

Aim To establish an HPLC method for determination of the content and its related substances of metformin hydroehloride tablets. Method A CN column was used,methanol-water（ 10：90） （0.003% triethylamine, hydrochloric acid adjusted to pH 5.4）as mobile phase with UV detection at 232 nm（content） and at 215 nm（ related substances）. Results The calibration curve was in good linearity over the range between 0.01 and 0.1 mg · L^-1 （ r = 0. 99998）. The average recovery, was 99.9% and RSD was 0.84% （ n = 9）. Conclusion The method was simple,reliable, accurate and can be used for the quality control of metformin hydrochloride tablets.