摘要
目的通过对羟乙基淀粉200/0.5残留量TOC检验方法的验证,确定羟乙基淀粉200/0.5残留量用该检验方法检测的定量限、线性、灵敏度和回收率(准确度),确保该方法对羟乙基淀粉200/0.5残留量浓度检测结果的准确性.方法总有机碳法.结果该检测方法的线性范围为0.200～2.000 ppm;检测方法的回收率为100.7%;擦拭法的回收率为73.0%;精密度与重复性良好;定量限为:0.002 ppm.确定了凡残留量0.002～2.000 ppm范围内均可采用此方法检测.结论此方法操作简单,精密度、准确度、重复性较好.
Objective To determine the quantification limit,linearity,sensitivity and recovery（accuracy）through validation of total organic carbon（TOC） method for determination of hydroxyethyl starch 200/0.5 residues,and to ensure the accuracy of TOC test results of the residual concentrations.Methods TOC method was adopted.Results The linear range was 0.200~2.000 ppm,the recovery of the determination method was 100.7% and the recovery of the cleaning method was 73.0%;the method was of good precision and reproducibility,and the quantification limit was 0.002 ppm.All residues within the range of 0.002~2.000 ppm can be determined by this method.Conclusion This method was simple to operate with high precision,accuracy and good reproducibility.
出处
《齐鲁药事》
2012年第7期410-411,共2页
qilu pharmaceutical affairs
