摘要
目的研究碘解磷定注射液中的杂质。方法采用双三元高效液相色谱仪-飞行时间质谱仪及核磁共振谱仪测定碘解磷定注射液中的杂质,并根据质谱和核磁的测定结果推测其结构。结果推测可能的杂质结构分别为:2-羧基-1-甲基吡啶碘化物、1-甲基-2-吡啶酮、2-氨基甲酰基-1-甲基吡啶碘化物、2-甲酰基-1-甲基吡啶碘化物、2-羟甲基-1-甲基吡啶碘化物、碘解磷定异构体、2-氰基-1-甲基吡啶碘化物。结论根据杂质结构分析碘解磷定可能的来源途径,可为其注射液的工艺改进和质量控制提供依据。
OBJECTIVE To investigate the impurities in Pralidoxime iodide injection. METHODS The impurities were separated and determined by DGLC - MS and NMR. The possible impurity structures were speculated by the results of spectrometry from mass and NMR. RESULTS The possible structures of these impurities were 2 - carboxy - 1 - methylpyridinium iodide, 1 - methyl - 2 - pyridone,2 -carbamoyl - 1 - methylpyridinium iodide, 2 - formyl - 1 - methylpyridinium iodide, and 2 - hydroxymethyl - 1 - meth- ylpyfidinium iodide, anti - pralidoxime iodide,2 - cyano - 1 - methylpyridinium iodide, respectively. CONCLUSION The important reference for the process improvement and quality control of Pralidoxime iodide injection are provided according to the analysis of possible sources by the structures of impurities.
出处
《华西药学杂志》
CAS
CSCD
2017年第1期87-89,共3页
West China Journal of Pharmaceutical Sciences
