Inter-laboratory Comparison of UPLC Determination of Polymers in Human Albumin and Evaluation of the Method Applicability / 中国药学杂志

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.