[关键词]
[摘要]
目的: 探讨采用高效液相色谱法测定盐酸二甲双胍肠溶片释放度。方法: 采用HPLC 法,流动相为
甲醇-水( 含2. 5 mmol /L 庚烷磺酸钠,0. 14% 三乙胺) ( 5 ∶ 95) ,用磷酸调pH 至7. 4,紫外检测器,检测波长
233nm。结果: 盐酸二甲双胍在31. 375 ~ 551. 0μg /mL 的浓度范围内线性良好,线性方程为Y = 75610 X+600( r
= 0. 9992) ; 平均回收率为102. 28%,RSD= 0. 75%。结论: HPLC 法测定盐酸二甲双胍肠溶片释放度,此方法准
确、灵敏度高,能够更好地控制药品质量。
[Key word]
[Abstract]
Objective: Research for release in vitro of Metformin Hydrochloride Enteric - coated
Tablets. Methods: HPLC method was adopted, the mobile phase was methanol-water( containing 2. 5
mmol /L sodium heptanes,0 . 14%triethylamine) ( 5 ∶ 95) ,adjusted to pH 7. 4 with phosphoric acid,
UV detector,detection wavelength of 233nm. Results: Metformin hydrochloride concentration range inside
31. 375 ~ 551. 0μg /mL,linear regression coefficient was 0. 9992; average recovery was
102. 28%,RSD= 0. 75%. Conclusion: Method of HPLC for the determination of the release of metformin
hydrochloride enteric-coated tablets was presents the superordinary accuracy,high sensitivity,
and better capability to control the quality of drugs.
[中图分类号]
R284. 1
[基金项目]
收稿日期: 2014-06-11; 修回日期: 2014-08-13
基金项目: 内蒙古自然科学基金项目( 2011MS1135)
作者简介: 魏青( 1966-) ,男,内蒙古医科大学附属医院副主任药师。