Application of UPLC/VION Mass Spectrometry in Quality Control of Recombinant Human Albumin / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the applicability of UPLC/MS method for the identification test of human serum albumin (HSA) products including plasma derived and recombinant HSA samples. METHODS: ACQUITY UPLC with Vion IMS QT of LC/MS system was used combined with on-line HSA sample desalting with ACQUITY UPLC BEH C18 column. The acquired multiplycharged mass spectrum was processed with MaxEnt1 automatic protein deconvolution software in UNIFI, which can transfer the raw mass spectrometry data to zero charge molecular mass or mass distribution of the intact protein. RESULTS: Intact protein mass analysis not only provided the accurate mass of HSA, but also provided an overall view of the heterogeneity of HSA and the relative amounts of various forms. From this study, a very specific mass signal [(66 437 ± 1), which is the theoretical average MW of human serum albumin ]was obtained from all the six HSA samples. And the characteristic spectra of different samples were also got. CONCLUSION: UPLC/MS method has very good specificity and high sensitivity and can distinguish HSA products made by different manufacturers and processes. The total analytical time is 10 min, which is ideal for the QC identification test of HSA products.