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HPLC法测定泮托拉唑钠肠溶胶囊的耐酸力
引用本文:徐慧娟,傅美景,雷锦璟.HPLC法测定泮托拉唑钠肠溶胶囊的耐酸力[J].黑龙江医药,2010,23(6):881-883.
作者姓名:徐慧娟  傅美景  雷锦璟
作者单位:杭州康恩贝制药有限公司,杭州,浙江,310052
摘    要:目的:建立测定泮托拉唑钠肠溶胶囊耐酸力的方法。方法:采用HPLC法,色谱柱为Hypersil ODS2C18(250×4.6mm,5μm),流动相为磷酸盐缓冲液(取磷酸氢二钠1.12g与磷酸二氢钠0.18g,加水溶解并稀释至1000ml)-乙腈(70:30),检测波长288nm,流速1.0ml/min。结果:泮托拉唑钠线性范围为8.16-81.56μg/ml(r^2=0.9993),平均回收率为99.05%,RSD=0.46%(n=9),三批样品耐酸力均大于95%。结论:所用方法简便快速,专属性强,灵敏度高,准确度好。

关 键 词:泮托拉唑钠  高效液相色谱法  耐酸力

Determination of Acid-resisting from Pantoprazole Sodium Enteric Coated Capsule by HPLC
Xu Huijuan,et al Hangzhou conba Pharmaceutial Co.,Ltd.Determination of Acid-resisting from Pantoprazole Sodium Enteric Coated Capsule by HPLC[J].Heilongjiang Medicine,2010,23(6):881-883.
Authors:Xu Huijuan  Hangzhou conba Pharmaceutial Co  Ltd
Institution:Xu Huijuan,et al Hangzhou conba Pharmaceutial Co.,Ltd(Hangzhou Zhejiang 310052)
Abstract:Objective:To establish a HPLC method for determination of acid- resisting of Pantoprazole sodium entericcoated capsule. Methods: Hypersil ODS2C 18 (250 × 4. 6mm,5um)columm was used. The mobile phase was phosphate buffer (disodium hydrogen phosphate 1.12g and sodium dihydrogen phosphate 1.18g was solved to 1000 ml water) -aeeotonirtrile (70:30). The detection wavelength was 288nm. The flow rate was 1.0ml/min. Results :The liner range of Pantoprazole sodium in this method was 8. 16 -81.56μg/ml (r^2 = 0. 9993 ). The averange recovery was 99. 05%, RSD = 0. 46% (n = 9 ). And the acid- resisting results of three samples are all greater than 95%. Conclusion:The method is aecurate,reliable,rapid and convenient.
Keywords:Pantoprazole Sodium  HPLC  Acid-resisting  
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