费休氏水分测定法测定注射用血栓通(冻干)的水分

Determination of Moisture Content of Xueshuantong(Lyophilized) for Injection by Fisher’s Method

目的:建立费休氏容量滴定法测定注射用血栓通(冻干)水分方法。方法:注射用血栓通(冻干)采用无吡啶卡尔-费休氏试液按中国药典费休氏容量滴定法测定,用无水甲醇作为溶剂,测定结果与减压干燥法的结果作对比。结果:减压干燥法的测定结果要比费休氏法稍高,但是两种检测方法的结果基本一致,费休氏容量滴定法的平均回收率101.2%,RSD为1.5%(n=6)。结论:卡尔-费休氏液对水的作用特别敏感,用费休氏法能准确测定样品中的微量水分,且费休氏水分测定法简便、快捷、灵敏度高、专属性强重现性好,可用于注射用血栓通(冻干)的水分测定。

Objective:A method for the determination of Xueshuantong(lyophilized)water for injection by Fischer volumetric titration was established.Methods:Xueshuantong for injection(lyophilized)was determined by pyridine free Karl-Fischer test solution according to Fischer volumetric titration in Chinese Pharmacopoeia,and anhydrous methanol was used as solvent.The results were compared with those of decompression drying method.Results:The results of vacuum drying method were slightly higher than those of Fisher's method,but the results of the two methods were basically the same.The average recovery of Fisher's volumetric titration was 101.2%,and the RSD was 1.5%(n=6).Conclusion:Karl-Fischer's solution is particularly sensitive to water.Fischer's method can accurately determine the trace water in the sample.Fischer's water determination method is simple,fast,high sensitivity,strong specificity and good reproducibility.It can be used for the determination of water in Xueshuantong(lyophilized)for injection.