HPLC法测定盐酸二甲双胍缓释片中盐酸二甲双胍的含量  

Content Determination of Metformin Hydrochloride Sustained-release Tablets by HPLC

作　　者：李艺[1] 王红[1] 张良珂[1] 赵春景[2] 张景勍[1] 

机构地区：[1]重庆医科大学高校药物工程研究中心和生物化学与分子药理重点实验室,重庆市400016 [2]重庆医科大学附属第二医院,重庆市400010

出　　处：《中国药房》2011年第24期2296-2297,共2页China Pharmacy

摘　　要：目的:建立测定盐酸二甲双胍缓释片中盐酸二甲双胍含量的方法。方法:采用高效液相色谱法。色谱柱为HypersilODS2柱为,2流0μ动L相,柱为温0为.053%0庚℃烷。磺结酸果钠:盐溶酸液二(用甲磷双酸胍溶检液测调浓节度p在H0至.114～.0)1-0乙.7腈0(μg8·4m∶1L6-)(1,r检=测0.波99长97为)范23围3内nm与,流峰速面为积1积.0分m值L·呈mi良n-好1,线进性样量关系;平均加样回收率为98.17%、99.69%、100.19%,RSD=0.60%。结论:本方法简便、准确,可用于二甲双胍缓释片的质量控制。OBJECTIVE： To establish the method for the content determination of main component of Metformin hydrochloride sustained- release tablets. METHODS：HPLC was conducted on a Hypersil ODS2 with mobile phase consisted of 0.05% sodium heptanesulfonate solution （pH adjusted to 4.0）-acetonitrile （84 ∶ 16） at a flow rate of 1.0 mL·min-1. The UV detection wavelength was set at 233 nm. The injection volume was 20 μL and the column temperature was 30℃. RESULTS： The linear range of metformin hydrochloride was 0.11～10.70 μg·mL-1 （r=0.999 7） with an average recovery of 98.17%, 99.69%, 100.19%（RSD=0.60%）. CONCLUSION： The method is simple and accurate for the content determination of Metformin hydrochloride sustained-release tablets.

关 键 词：高效液相色谱法 盐酸二甲双胍缓释片 含量测定 

分 类 号：R917[医药卫生—药物分析学]