UPLC测定人血白蛋白多聚体含量方法的实验室间比对与适用性论证

Inter-laboratory Comparison of UPLC Determination of Polymers in Human Albumin and Evaluation of the Method Applicability

目的对UPLC测定人血白蛋白多聚体含量的方法进行实验室间比对和适用性论证。方法向6家实验室发放来自国内外生产企业的人血白蛋白样品20份、人血白蛋白国家参考品合计21份样品,采用UPLC测定多聚体含量并用HPLC方法平行测定,开展实验室间比对和UPLC方法的适用性论证。结果4家同时具备HPLC和UPLC条件的实验室平行比对显示,UPLC方法与现有药典HPLC方法实验室内结果比较无显著性差异(P>0.05)。6家实验室UPLC测定21份样品结果均值与4家实验室HPLC方法测定结果均值配对t检验(P>0.05),UPLC方法实验室间无显著性差异。6家协作实验室间UPLC法对21份样本平行测定结果标准差SD的均值仅为0.06,相对标准偏差RSD的均值仅为1.04%;而HPLC方法对21份样本平行测定标准差SD的均值为0.14,相对标准偏差RSD的均值为2.33%,提示UPLC方法测定结果的实验室间差异更小。结论UPLC测定人血白蛋白多聚体与现有HPLC方法实验室间比对结果一致性高,但UPLC方法更为快速高效,测定结果的实验室间差异性更小,显著优于现有HPLC方法。

OBJECTIVE To conduct an inter-laboratory comparison of UPLC method for polymer determination in human serum albumin and verify the method applicability.METHODS National reference of human serum albumin and 20 samples of human serum albumin from domestic and foreign manufactures were distributed to six laboratories in order to carry out inter-laboratory comparison and demonstration of applicability.UPLC was used to determine the content of polymer and HPLC method was used for parallel comparison.RESULTS There was no significant difference in the determination results between the UPLC method and current HPLC method in four laboratories(P>0.05)equipped with both HPLC and UPLC.The mean values of 21 samples measured with UPLC method by six laboratories were matched with those measured with HPLC method by four laboratories(t test P>0.05).The mean values of standard deviation(SD)and relative standard deviation(RSD)for 21 samples by UPLC method were only 0.06 and 1.02%respectively.The mean values of standard deviation(SD)and relative standard deviation(RSD)were 0.14 and 2.33%for parallel 21 samples determination by HPLC method,suggesting that the difference of UPLC test results between laboratories was smaller.CONCLUSION The results=of UPLC method are in good agreement with those of HPLC method.UPLC method is more effective and efficient,with smaller inter-laboratory difference,thus is significantly better than the HPLC method.