Abstract
Objective To modify pharmacopoeia method (O-acetyl group assay) for quantitative detection of O-acetyl group content in typhoid Vi polysaccharide vaccine using low concentration control, and validate the feasibility of the modified method. Methods The standard curve of the modified method was established using control solution containing 0.05, 0.10, 0.20, 0.30, 0.40, 0.50 μmol of acetylcholine bromide, and the standard curve linearity, accuracy, precision, specificity and durability of the modified method were validated. Results The standard curve linearity was good, with coefficient of determination ﹥0.998. The accuracy, precision and specificity were all good, the recoveries of O-acetyl group were 99.8%-101.3%, the relative standard deviations of intra- and inter-assay were both ﹤4%, and the recoveries of added O-acetyl group were all ﹥96%. The limit of quantitation of O-acetyl group was 0.070 mmol/L. Conclusion The modified method using low concentration control can be used for quantitative detection of O-acetyl group content in typhoid Vi polysaccharide vaccine. Key words: Spectrophotometry, ultraviolet; Bacterial vaccines; O-acetyl group
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