关于维库溴铵高效液相色谱分析中主要共存杂质的分离问题——部颁标准和欧洲药典方法的比较  

On the Separation of Main Co-existing Impurities in HPLC Analysis of Vecuronium——A Comparative Study on the Methods Given in Ministerial Standards and in Europo-pharmacopoeia

作　　者：莫满芳[1] 曾常青[1] 张志福[1] 罗中成 孙悦[1] 

机构地区：[1]广东药学院中药学院,广州510006

出　　处：《理化检验（化学分册）》2013年第11期1344-1348,共5页Physical Testing and Chemical Analysis(Part B:Chemical Analysis)

摘　　要：对现行的部颁标准和欧洲药典中高效液相色谱分析维库溴铵时其主要共存杂质的有效分离问题作了比较试验。由于尚无含有已知共存杂质的维库溴铵标准样品，试验中将5份含有较多杂质的样品经不同方法破坏后用作分析物。结果表明：虽经对色谱分离中所用流动相的2组分的配比以及其酸度作了优化试验，部颁标准方法都不能有效地使样品中的杂质峰很好分离。但采用欧洲药典方法可达到样品主峰和主要杂质峰的良好分离，试验了流动相在pH6．5～8．0之间酸度变化的影响，证明采用pH7．5的流动相分离效果更好。A comparative study on the efficiency of separation of main co existing impurities in HPLC analysis of vecuronium by methods given in the ministerial standards of China and in Europo pharmacopoeia. Due to lack of vecuronium standard sample with known contents of main co-existing impurities, 5 portions of a vecuronium sample with significant amounts of the main co existing impurities were destroyed and used as analytes in the testing. It was shown that effective separation of the main impurities was not attained by the present Chinese standards, even with optimization of the mixing ratio of the components and the pH condition of the mobile phase. Howevcr, by applying the condition of chromatographic separation given by the HPI.C method of Europo pharmacopoeia, good separation between the main peak of vecuronium and peaks of the main impurities, and by modifying the acidity of its mobile phase to pH 7.5, more effective separation was obtained.

关 键 词：高效液相色谱法 维库溴铵 主要共存杂质 流动相 部颁标准 欧洲药典 

分 类 号：O652.63[理学—分析化学]