HPLC同时测定复方盐酸二甲双胍格列苯脲片中盐酸二甲双胍及格列苯脲的含量

Determination of Metformin Hydrochloride and Glibenclamide in Compound Metformin Hydrochloride and Glibenclamide Tablets by HPLC

目的建立HPLC方法同时测定复方盐酸二甲双胍格列苯脲片中盐酸二甲双胍及格列苯脲的含量。方法采用VP-ODS（4.6 mm×250 mm,5μm）色谱柱,以甲醇-0.03mol.L^-1磷酸二氢铵的0.025%十二烷基磺酸钠溶液（用磷酸调节pH值至3.5±0.05）（67∶33）为流动相,流速为1.0 mL.min^-1,柱温30℃,检测波长为215 nm。结果盐酸二甲双胍在0.031 25～0.312 5 g.L^-1（0.625～6.25μg）的范围内呈良好的线性关系,r=0.999 6,平均回收率为99.8%,RSD=0.4%;格列苯脲在0.156 2～1.562 mg.L^-1（3.124～31.24 ng）的范围内呈良好线性关系,r=0.999 7,平均回收率为99.9%,RSD=0.6%。结论该方法实现了同时测定盐酸二甲双胍及格列苯脲的目的,并且方法简便,准确稳定,重现性好。

OBJECTIVE To establish a HPLC method for the determination of metformin hydrochloride and glibenclamide in metformin hydrochloride and glibenclamide tablets.METHOD A VP-ODS（4.6 mm×250 mm,5 μm） column was adopted with methanol-water（the water phase was composed of 0.03 mol·L-1 ammonium dihydrogen phosphate and 0.025% sodium laurylsulfate adjust pH to 3.5±0.05 with phosphoric acid）as mobile phase at 1.0 mL·min-1.The detection wavelenth was 215 nm and column temperature was 30 ℃.RESULTS The linear range of metformin hydrochloride was obtained between 0.031 25～0.312 5 g·L-1（0.625～6.25 μg）,r=0.999 6.The average recovery was 99.8%.with RSD of 0.4%.The linear range of glibenclamide was obtained between 0.156 2～1.562 mg·L-1（3.124～31.24 ng）,r=0.999 7,The average recovery was 99.9%.（RSD=0.6%）.CONCLUSION The method is simple,accurate,reproducible and can be used for determination of metformin hydrochloride and glibenclamide in metformin hydrochloride and glibenclamide tablets.