文章摘要
陈冬华.泮托拉唑钠肠溶片溶出度的研究[J].中国药品标准,2019,20(6):
泮托拉唑钠肠溶片溶出度的研究
Study on Dissolution Determination of Pantoprazole Sodium Enteric Tablets
投稿时间:2019-04-04  修订日期:2020-02-10
DOI:
中文关键词: 泮托拉唑钠肠溶片  溶出度测定  高效液相色谱法
英文关键词: Pantoprazole sodium enteric tablets  Solubility detection  HPLC
基金项目:
作者单位E-mail
陈冬华 广东省药品检验所 cdh0083@163.com 
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中文摘要:
      目的 建立的泮托拉唑钠肠溶片的溶出度测定方法。方法 参考《中国药典》2015年版四部通则溶出度与释放度测定法要求,建立HPLC法测定样品中泮托拉唑钠的溶出量 ,并进行方法学验证,同时将所建方法与国内现行标准方法的结果比较。结果 泮托拉唑钠浓度在3.57~89.33μg.mL-1范围内线性关系良好(r=0.9999),回收率在 98 %~101 %内,精密度RSD<1.5%。仅有两个厂家产品体外溶出曲线与原研参比制剂相似。结论 该方法区分度高,专属性强,精密度好,结果准确,适用性好,可用于泮托拉唑钠肠溶片溶出度测定的质量控制。
英文摘要:
      Objective To establish a method for dissolution of Pantoprazole Sodium Enteric Tablets. Methods The dissolution method of Pantoprazole Sodium Enteric Tablets,referring to the dissolution assay of Chinese Pharmacopoeia 2015 vol Ⅳ,was determined with HPLC. We methodologically validated the dissolution method.Moreover,the results of this method were compare with those of current domestic stander. Results There was a linear relationship between Pantoprazole Sodium concentration and peak area within the concentration range of 3.57-89.33 ug.mL-1 (r=0.9999), The recovery was 98%-101% and RSD was less than 1.5%.Only tow enterprises’ preparations match the reference preparation with dissolution curves. Conclusion The method is distinguishing,specific, accurate,applicable and suitable for the quality control of Pantoprazole Sodium Enteric Tablets.
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