左乙拉西坦原料药细菌内毒素检查方法学研究

Methodological study of bacterial endotoxin test of levetiracetam active pharmaceutical ingredients

目的:研究左乙拉西坦原料药细菌内毒素检查方法,对凝胶法和动态显色法两种试验方法进行比较。方法:按照《中国药典》2020年版四部通则1143“细菌内毒素检查法”,用凝胶法和动态显色法两种试验方法,对3批样品进行干扰试验以及细菌内毒素检查。结果:将左乙拉西坦原料药细菌内毒素限值定为“每1mg左乙拉西坦中含内毒素的量应小于0.03 EU”,左乙拉西坦对凝胶法和动态显色法两种试验方法均无干扰作用,细菌内毒素检查结果符合规定。结论:凝胶法和动态显色法均可用于左乙拉西坦原料药细菌内毒素检测,可根据不同的需求,选择适合的检测方法。

Objective:The method of bacterial endotoxin detection of levetiracetam was investigated,and the gel method and dynamic color development method were compared.Methods:According to the Chinese Pharmacopoeia 2020 part Ⅳ general rule 1143 “Bacterial endotoxin detection method”,three batches of samples were subjected to interference test and bacterial endotoxin test by gel method and dynamic chromogenic method.Results:The limit of bacterial endotoxin of levetiracetam API was set as “the amount of endotoxin contained in levetiracetam per 1 mg should be less than 0.03 EU”,levetiracetam had no interfering effect on the two test methods of gel method and dynamic chromogenic method,and the results of bacterial endotoxin test were in line with the regulations.Conclusion:Both gel method and dynamic chromogenic method can be used for the detection of bacterial endotoxin of levetiracetam API,and the appropriate detection method can be selected according to different needs.