盐酸左氧氟沙星细菌内毒素检查法研究

Investigation on bacterial endotoxin test method for levofloxacin hydrochloride

目的:建立盐酸左氧氟沙星细菌内毒素的常规检测方法。方法:按《中国药典》2020年版通则1143细菌内毒素检查法进行,采用不同厂家的鲎试剂对不同批号的盐酸左氧氟沙星分别进行干扰试验。结果:在验证条件下,供试品用碱性调节剂溶解,制备成10 mg·mL^(-1),并用稀释剂稀释至2.5 mg·mL^(-1)后再用BET水稀释至1.25 mg·mL^(-1),对细菌内毒素检查法无干扰作用。结论:建立的方法用于检查盐酸左氧氟沙星的细菌内毒素可行。

Objective:To establish a bacterial endotoxin test method for levofloxacin hydrochloride.Methods:The bacterial endotoxin test was carried out according to the general chapters 1143 of the Chinese Pharmacopoeia 2020 VolⅣ.The interference test was performed with the different batches of levofloxacin hydrochloride and TALs from different manufacturers.Results:There was no interference for bacteria endotoxin test that under the validation condition,the sample was dissolved to 10 mg·mL^(-1) with alkalizer.Then the obtained solution was diluted to 2.5 mg·mL^(-1) with the diluent,and was diluted to 1.25 mg·mL^(-1) with BET water finally.Conclusion:The established method is applicable to bacterial endotoxin test of levofloxacin hydrochloride.