HPLC法测定奥硝唑注射液中奥硝唑含量的不确定度分析  

Uncertainty analysis of Ornidazole in Ornidazole Injection by HPLC

作　　者：庄晓庆 

机构地区：[1]江苏省南通药品检验所,南通226006

出　　处：《海峡药学》2012年第7期48-50,共3页Strait Pharmaceutical Journal

摘　　要：目的分析HPLC法测定奥硝唑注射液中奥硝唑含量的不确定度。方法通过建立HPLC法测定含量的数学模型,找出影响不确定度的因素,并对各个不确定度因素进行评估、计算,由此计算合成不确定度,最终给出测量结果的扩展不确定度。结果合成不确定度为0.71,扩展不确定度U=1.4%(k=2)。结论本方法可以用于HPLC法测定药物含量的不确定度评定。OBJECTIVE To analyze the uncertainty of Ornidazole in Omidazole injection by HPLC. METHODS Through establishing HPLC assay mathematical model, the factors afffecting the uncertainty were deduced. Each component of uncertainty was evaluated, from which the combined uncertainty and the extended uncertainty were obtained. RESULTS The combined uncertainty was 0.71 and the extended uncertainty was 1.4 % （k = 2）. CONCLUSION The established analytical method can be used to the uncertainty assay.

关 键 词：不确定度 高效液相色谱法 含量测定 奥硝唑 

分 类 号：R927.2[医药卫生—药学]