摘要
目的建立同时测定复方盐酸二甲双胍片中格列美脲和盐酸二甲双胍含量的方法。方法采用RP-HPLC法。色谱柱为Diamonsil C18柱(150 mm×4.6 mm,5μm),流动相为乙腈-20 mmol.L-1磷酸氢二钠溶液(含8 mmol.L-1十二烷基硫酸钠,磷酸调pH值7.5)(体积比为33∶67),流速为1 mL.min-1,检测波长为228 nm。结果格列美脲和盐酸二甲双胍的线性范围分别为0.1～0.6 mg.L-1(r=0.999 1,n=6)和25.0～150.0 mg.L-1(r=0.999 6,n=6);平均回收率分别为99.4%(RSD=1.0%,n=9)和99.8%(RSD=0.39%,n=9)。结论本方法简便、准确,可用于复方盐酸二甲双胍片的质量控制。
Objective To establish an RP-HPLC method for the simultaneous determination of glimepiride and metformin hydrochloride in compound metformin hydrochloride tablets.Methods The separation was performed on a Diamonsil C18（150 mm×4.6 mm,5 μm）column with a mobile phase consisted of acetonitrile-phosphate buffer（pH 7.5,V∶ V=33∶ 67） at a flow rate of 1.0 mL · min-1.The detection wavelength was set at 228 nm.Results The linear range was 0.1-0.6 mg · L-1（r=0.999 1,n=6）,and the average recovery was 99.4%（RSD=1.0%,n=9）for glimepiride;the linear range was 25.0-150.0 mg · L-1（r=0.999 6,n=6）,and the average recovery was 99.8%（RSD=0.39%,n=9）for metformin hydrochloride.Conclusions The method is simple,accurate and reproducible,which can be used for determination of metformin hydrochloride and glimepiride in compound metformin hydrochloride tablets.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2013年第5期362-365,373,共5页
Journal of Shenyang Pharmaceutical University
