Inter-laboratory Comparison of UPLC Determination of Polymers in Human Albumin and Evaluation of the Method Applicability
WANG Min-li1, HOU Shu-ting2, SONG Lan-kun3, HE Yong-bing4, MA Li5, FU Long6, SHAO Hong7, HAN Zhi-guo3, HOU Ji-feng1*
1. National Institutes for Food and Drug Control, WHO Collaboration Center for Standardization and Evaluation of Biologicals, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing 100050, China; 2. School of Life Sciences, Peking University,Beijing 100871, China; 3. Waters Technologies (Shanghai) Co.,Ltd., Shanghai 201206, China; 4. Sichuan Yuanda Shuyang Pharmacemutical Co.,Ltd., Chengdu 610214, China; 5. Hualan Biological Engineering, Inc, Xinxiang 453003, China; 6. Waters Pharmacopoeia Joint Laboratory, Beijing 100050, China; 7. Shanghai Institutes for Food and Drug Control, Shanghai 201203, China
Abstract：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.
王敏力, 侯书婷, 宋兰坤, 何永兵, 马力, 付龙, 邵泓, 韩治国, 侯继锋. 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[J]. 中国药学杂志, 2019, 54(20): 1685-1691.
WANG Min-li, HOU Shu-ting, SONG Lan-kun, HE Yong-bing, MA Li, FU Long, SHAO Hong, HAN Zhi-guo, HOU Ji-feng. Inter-laboratory Comparison of UPLC Determination of Polymers in Human Albumin and Evaluation of the Method Applicability. Chinese Pharmaceutical Journal, 2019, 54(20): 1685-1691.
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2019, Vol. 54 
