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pH 6.5~8.0之间酸度变化的影响,证明采用pH 7.5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. However, by applying the condition of chromatographic separation given by the HPLC 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.