高效液相色谱法测定注射用左亚叶酸钠有关物质的研究

Determination of Related Substances in SodiumLevofloxacin for Injection by HPLC

左亚叶酸钠水溶液不稳定,尤其对光和热较敏感,考虑到左亚叶酸钠水溶液的稳定性较差,我们研制了稳定性较好的左亚叶酸钠冻干制剂,即注射用左亚叶酸钠。为了研究本品有关物质情况,我们参考了中国药典二部亚叶酸钙质量标准及《欧洲药典》左亚叶酸钙质量标准进行研究,但发现现有方法在测定本品时,有些杂质无法基线分离,因此我们对方法进行摸索改进,找出更佳的色谱条件,并使已知杂质10-甲酰叶酸能得到准确测定。

Sodium leucovorin solution is unstable,especially sensitive to light and heat.Considering its poor stability,a lyophilized preparation with better stability of sodium leucovorin solution was developed,namely,sodium leucovorin for injection.In order to research related materials of sodium leucovorin for injection,the calcium leucovorin quality standards from both China pharmacopeia and European pharmacopoeia were referenced.But under the existing methods in determining the product,some impurities cannot achieve a baseline separation,so better chromatographic conditions were groped.As a result,the content of known impurity 10-formyl folic acid can be determined accurately.