HPLC法测定埃索美拉唑镁肠溶微丸胶囊中主药的含量  

Determination of Esomeprazole Magnesium Enteric-coated Pellets Capsules by HPLC

作　　者：林缨缨[1] 廖华卫[2] 

机构地区：[1]广州医学院第二附属医院药学部,广州510260 [2]广东药学院中药学院

出　　处：《中国药师》2013年第12期1849-1851,共3页China Pharmacist

摘　　要：目的:建立以HPLC法测定埃索美拉唑镁肠溶微丸胶囊中埃索美拉唑镁含量的方法。方法:以Kromasil C_(18)(250 mm×4.6 mm,5μm)为色谱柱,流动相为乙腈-0.1 mol·L^(-1)磷酸盐溶液(用磷酸调节pH=7.6)=35:65,检测波长为280 nm,流速为1.0 ml·min^(-1),柱温为30℃,进样量是20μl。结果:埃索美拉唑镁在20.18~201.80μg·ml^(-1)范围内进样量与峰面积呈良好的线性关系(r=0.999 7),平均回收率为100.1%,RSD=0.8%。结论:本法简便、准确、专属性强,可用于试制剂的含量测定。Objective：To establish a method for the determination of esomeprazole magnesium enteric-coated pellets capsules. Method：The HPI,C method was perfonned on a C18（250 mm×4.6 mm,5 μm） column using acetonitrile-0.1 mol？L-1 phosphate buffer solution（35：65,adjusting pH to 7.6 with phosphate） as the mobile phase at a flow rate of 1.0 ml ？ min-1.The detection wavelength was at 280nm.The column temperature was 30℃ and the injection volume was 20 μl.Result：The linear range of esomeprazole magnesium was 20.18-201.80 μg？ml-1（r = 0.999 7）,and the average recovery was 100.1%（RSD = 0.8%）.Conclusion： The method is simple,accurate and special,and can be used in the quality control of esomeprazole magnesium enteric-coated pellets capsules.

关 键 词：埃索美拉唑镁肠溶微丸胶囊 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学]