HPLC测定复方盐酸二甲双胍格列美脲胶囊中的格列美脲  

Determination of glimepiride in Complex metformin hydrochloride-glimepiride capsules

作　　者：白靖[1] 曹亮[1] 张倩 方瑜[1] 曹德英[1] 

机构地区：[1]河北医科大学药学院,河北石家庄050017 [2]石药集团,河北石家庄050017

出　　处：《华西药学杂志》2012年第4期438-440,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的用HPLC法测定复方盐酸二甲双胍格列美脲胶囊中格列美脲的含量。方法采用Diamonsil C18色谱柱(250mm×4.6 mm,5μm),流动相为0.05 mol·L-1甲酸铵缓冲液(pH4)-乙腈(40∶60),检测波长228 nm,流速1.0 mL·min-1。结果 1.014～20.280μg·mL-1格列美脲与峰面积呈良好的线性关系(r=0.9999),平均回收率为99.5%,RSD=1.0%。结论所用方法简便、准确性高、专属性强,且盐酸二甲双胍对格列美脲的测定无干扰,可用于该类复方制剂的质量控制。OBJECTIVE To establish an HPLC method for content determination of glimepiride in Complex metformin hydrochloride-glimepiride capsules.METHODS The chromatographic separation was performed on a Diamonsil C18 column（250 mm×4.6 mm,5 μm）.The mobile phase consisted of 0.05 mol·L-1 ammonium formate（pH4）and acetonitrile（40：60） at a flow rate of 1.0 mL·min-1,with detection wavelength of 280 nm.RESULTS The calibration curves showed a good linearity within the range of 1.014-20.280 μg·mL-1 for glimepiride（r=0.9999）.The mean recovery was 99.5% with the RSD of 1.0 %.CONCLUSION It is a simple,accurate and specific method with no interference between metformin hydrochloride and glimepiride.It should be a referred method for determination of the content of glimepiride in the complex formulations containing glimepiride.

关 键 词：盐酸二甲双胍 格列美脲 高效液相色谱法 含量 

分 类 号：R917[医药卫生—药物分析学]