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

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

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AgilentZorbaxSB-C18柱,(4.6mm×250mm,5μm);A相(0.1%三氟乙酸)-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。

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.