Validation of GF-AAS Method for the Determination of Aluminium Content in Human Albumin Finished Product

Abstract

Background: Purified human albumin fractionated from plasma has a complex matrix that imposes a lot of interference in quality control testing, particularly for impurities at trace level. In this study, a simple approach has been studied and validated for the quantification of aluminium content using Graphite Furnace Atomic Absorption Spectrometry (GF-AAS). As per international guidelines, the linearity, accuracy, precision, specificity, limit of detection, and quantification have been assessed. Results: The linearity of the analyte response was evaluated over the range of concentrations from 5μg/L to 45 μg/L, and the correlation coefficient obtained was greater than 0.99. The mean recovery obtained for the accuracy ranged from 102.29% to 106.81% at three concentration levels. The specificity/selectivity evaluated for possible interference from other metal ions and relative standard deviation for the high and low content was 10.24% and 6.50%, respectively, which was statistically verified and not significant. Method precision was evaluated for repeatability and intermediate precision, and the relative standard deviation obtained was 1.83% and 4.61%, respectively. The limit of detection and quantification obtained was 1.30 μg/L and 4.10 μg/L, respectively. Conclusion: Results obtained for the method performance show the suitability of the method for aluminium estimation in human albumin samples and should be used to control the limit of aluminium in human albumin blood products.