摘要
目的建立费休氏容量滴定法测定盐酸多柔比星植入剂水分。方法用N,N-二甲基甲酰胺-甲醇混合溶剂溶解供试品制成溶液。用水-甲醇标准溶液标定费休氏试液后,先测定混合溶剂水分,再测定供试品溶液总水分,扣除混合溶剂水分后,得供试品水分。结果用混合溶剂溶解样品速度快,操作简单,可避免环境中水分的影响。费休氏试液标定偏差小,速度快。该方法重复性和日间精密度的RSD分别为1.24%(n=6)和1.32%(n=12),加标回收率在98%~102%之间,3批供试品水分在1.152%-1.233%范围内。结论费休氏容量滴定法可用于测定盐酸多柔比星植入剂水分。
Objective To establish a volumetric Fischer titration method for determination of water in doxorubicin hydrochloride implants. Methods The implants were dissolved by N,N-dimethylformamide and methanol mixed solvents. Firstly,Fischer reagent was calibrated by water-methanol standard solution. Then water in the mixed solvent(W0) and water in the implants solution(W1) were determined respectively. Finally, water in the implants was got by W1 minus WO. Results The implants solution was prepared quickly and simply avoiding environmental water influence. Fischer reagent was titrated quickly and accurately. The RSDs of repeatability and interday precision were 1.24%(n = 6) and 1.32%(n = 12) respectively. The recoveries of water were 98%-102%. Conclusion This method is validated by methodology and suitable for determination water in the implants.
出处
《安徽医药》
CAS
2018年第2期232-234,共3页
Anhui Medical and Pharmaceutical Journal
关键词
盐酸多柔比星植入剂
水分测定
费休氏容量滴定法
溶解转移
费休氏试液标定
doxorubicin hydrochloride implants
water determination
volumetric fischer titration
dissolution and transfer
fischer reagent calibration
