摘要
目的分析高效液相色谱法测定甘露醇冲洗液中甘露醇含量的不确定度。方法通过建立高效液相色谱法测定含量的数学模型,找出影响不确定度的因素,计算合成不确定度,给出扩展不确定度和置信水平。结果合成不确定度为0.512 9%,扩展不确定度为1.02%,含量测定的结果为(100.76±1.02)%。结论本方法可用于高效液相色谱法测定药物含量的不确定度分析。
Objective To analyze the uncertainty involved in HPLC method for the determination of mannitol in Mannitol Flushing Fluid.Methods Through establishing HPLC mathematical model,the factors affecting the uncertainty were deduced,composed uncertainty was calculated and finally the expanded uncertainty and condence level were obtained.Results The composed uncertainty was 0.512 9%,the expanded uncertainty was 1.02%,and the result of content determination was（100.76±1.02）%.Conclusion This method can be used for the uncertainty analysis of determination of medicines by HPLC.
出处
《齐鲁药事》
2012年第12期714-716,共3页
qilu pharmaceutical affairs
