泮托拉唑钠有关物质分析方法的比较

Comparison of analytical methods for related substances of pantoprazole sodium

目的比较并讨论《美国药典》和《中国药典》中泮托拉唑钠有关物质的检测方法,为完善泮托拉唑钠肠溶胶囊及肠溶片中泮托拉唑钠有关物质的检测方法提供科学依据。方法采用InertsilO DS-3柱(梯度方法100mm×4.0mm,5μm;等度方法250mm×4.6mm,5μm),分别用《中国药典》2005年版(ChP2005)、2010年版(Chp2010)和美国药典32-NF27版(USP32-NF27)原料及制剂方法测定泮托拉唑钠有关物质,并对其专属性及酸破坏结果进行比较。结果 ChP2010与USP32-NF27原料方法专属性优于另外两种方法,能将泮托拉唑钠及其有关物质较好地分离,二者分离效果基本一致,检出杂质的量也基本一致,各杂质相对保留时间近似相同。结论 ChP2010尚无关于片剂或胶囊剂质量标准的相关规定。泮托拉唑钠肠溶胶囊国家药品标准WS1-(X-198)-2004Z与泮托拉唑钠肠溶片国家药品标准WS1-(X-120)-2003Z中有关物质检查项仍沿用ChP2005方法,检出杂质较少,无法客观评价其质量。因此建议将泮托拉唑钠肠溶胶囊国家药品标准及泮托拉唑钠肠溶片国家药品标准有关物质检查方法改为更能客观评价其质量的ChP2010泮托拉唑钠原料有关物质检查方法,并对杂质峰的位置及单一杂质限度作出详细规定。

Objective To optimize the method for the determination of the related substances of Pantoprazole Sodium after comparing different HPLC methods in the United States Pharmacopeia （USP） and Chinese Pharmacopoeia （ChP）. Metohods Two Inertsil ODS-3 columns （100 mm×4.0 mm, 5μm for gradient elution and 250 mm×4.6 ram, 5 p.m for isocratic elution） were used according to the method in ChP 2005, ChP 2010, as well as the USP 32-NF 27 methods for bulk drug and pharmaceutics, respectively, and the results of specificity and destructive tests were compared. Results The ChP 20 l0 and USP 32-NF 27 methods for the bulk drug, with consistent resolution, content, and retention time of the impurities, are of higher specificity than the others and could separate the related substances ofpantoprazole sodium well. Conclusion Since there is no quality specification about cuteric-coated capsules and tablets of Pantoprazole Sodium in ChP 2010, the method to determine the related substances of Pantoprazole Sodium enteric-coated capsules and tablets is still referred from ChP 2005 although with low specificity. The ChP 2010 method applied to the determination of the related substances of bulk drug is proposed to determine the related substances of pantoprazole sodium enteric-coated capsules and tablets, with the retention time and content limit of each impurity specified.