用HPLC法检查法莫替丁氯化钠注射液有关物质时的问题和讨论

目的：用新建HPLC法考察了6个厂家18批法莫替丁氯化钠注射液中的有关物质。方法：采用Agilent Zorbax SB-C18柱，（4．6mm×250mm,5μm）；A相（0．1％二氟乙酸）-B相（乙腈）为流动相；流速：1．0mL·min^-1；梯度洗脱；检测波长为254nm；柱温为室温；结果：用本文新建方法和国家药品标准方法分别对18批样品有关物质检查结果进行了比较，结果前者检查有关物质检查总量比后者高约2％～6％。结论：本法简便、准确、专属性好，灵敏度高，可用于法莫替丁氯化钠注射液中有关物质的检查。

Discussion on Determination of Related Substances in Famotidine Sodium Chloride Injection by HPLC

Objective ：To establish an HPLC method to determine related substances in 18 batches of Famotidine Sodium Chloride Injection samples of 6 companies. Method：The HPLC method was conducted on an Agilent Zorbax SB-C18 column（4. 6 mm × 250 mm,5μm）and coupled with UV detector at 254 nm. The mobile phase was consisted of solvent A-0. 1% Triltuoroacetic acid and solvent B- acetonttrile with gradient elution program. The flow rate was 1.0 mL · min^-1 and the column temperature was room temperature. Result：The content of related substances in 18 samples by the new method and the WS1 -（ X-063 ）-2004Z method has been compared , and the contents of related substances by the former method are larger than the latter one by2% - 6%. Conclusion：A simple , accurate and sensitive HPLC method to determine related substances in Famotidine Sodium Chloride Injection Was established.