非水滴定法称样量对于注射用氨甲环酸含量测定的影响

Effect of Sample Weighting in Non-Aqueous Titration on the Determination of Tranexamic Acid for Injection

目的:通过不同的称样量对注射用氨甲环酸含量的影响,来验证所采用的分析方法的科学性、准确性和可行性。方法:取三批次注射用氨甲环酸产品,采用不同的称样量、不同的检验人员、液相所测得的含量结果等数据进行比对;通过重复性试验、中间精密度来进一步进行论证。结论:非水滴定法样品的称样量对于注射用氨甲环酸含量测定影响不大,且称样量0.12 g左右消耗高氯酸滴定液的体积约8 mL更符合《中国药典》(2020年版)、《中国药品检验标准操作规范》(2019年版)对称样量的要求。

Objective:To verify the scientificity,accuracy and feasibility of the analytical method by the effect of different sample weights on the content of tranexamic acid for injection.Methods:Three batches of tranexamic acid for injection were taken and compared with different sample weights,different inspectors and the content results measured by liquid phase;it is further demonstrated through repeatability test and intermediate precision.Conclusion:The sample weight of nonaqueous titration method has little effect on the determination of tranexamic acid for injection,and the sample weight is about 0.12 g,and the volume of perchloric acid titrant consumed is about 8 mL,which is more in line with the requirements of symmetrical sample weight in Chinese Pharmacopoeia(2020 Edition)and Chinese Standard Operating Specifications for Drug Inspection(2019 Edition).