摘要
目的:评估高效液相色谱(HPLC)法测定注射用哌拉西林钠含量的不确定度。方法:借助数学模型,找出影响不确定度的因素,包括标准品的称量、纯度、色谱峰面积以及供试品的称量、稀释和色谱峰面积等8种因素,并对各个不确定度分量进行评定,计算合成不确定度和扩展不确定度。结果:各分量的相对标准不确定度中以标准品和供试品的色谱峰面积影响最大;合成不确定度和扩展不确定度分别为0·48%和0·96%(P=95%,K=2),由标准品带来的不确定性较大。结论:测量不确定度可用于对注射用哌拉西林钠含量测定结果的评定。
OBJECTIVE： To assay the uncertainty for the content determination of Piperacillin sodium for injection by HPLC. METHODS ： The mathematic model was established to identify the 8 kinds of influencing factors of uncertainty, including weight- ing, purity and peak area of substance control and weighting, dilution and peak area of test sample, etc. And then the components of uncertainty were also evaluated, and combined uncertainty and expanded uncertainty were calculated. RESULTS： Relative stan- dard uncertainty of each component was greatly affected by the peak area of substance control and test sample; the combined uncer- tainty and expanded uncertainty were 0.48% and 0.96% （P=-95% ,K=2）, and the results showed that the substance control result- ed in greater uncertainty. CONCLUSION： The uncertainty assay can be used to evaluate the content determination of PiperaciUin so- dium for iniection.
出处
《中国药房》
CAS
CSCD
2012年第21期1997-1999,共3页
China Pharmacy
