The application of acetylacetone colorimetric method for determination of free formaldehyde content in influenza vaccine (split virion)

Abstract

Objective To validate feasibility of using acetylacetone colorimetric method for determination of free formaldehyde content in influenza vaccine (split virion),and to confirm the acetylacetone colorimetric method was better than the magenta sulphurous acid colorimetric method.Methods The accuracy,precision,specificity,linearity and durability of the acetylacetone colorimetric method were validated.The acetylacetone colorimetric method was compared with the magenta sulphurous acid colorimetric method.Results The standard curve of the acetylacetone colorimetric method was reliable,recoveries of formaldehyde were 100.3％-100.9％ and relative standard deviation (RSD) was 0.49％.The precision and specificity of the acetylacetone colorimetric method were good,RSDs of intra-assay and inter-assay were both ＜5.0％ and recoveries of formaldehyde were ＞99.0％.The acetylacetone method had better linearity and lower deviation as compared with the magenta sulphurous acid colorimetric method.Conclusion The acetylacetone colorimetric method for the determination of free formaldehyde content in influenza vaccine (split virion) is feasible. Key words: Colorimetry; Formaldehyde; Influenza vaccines