Title: Optimization and verification of determination method for residual deoxysodium cholate content in pneumococcal polysaccharide
Abstract: Objective To optimize the determination method for residual deoxysodium cholate content in pneumococcal polysaccharide. Methods The determination method for residual deoxysodium cholate content in bulk of pneumococcal polysaccharide was verified for suitability by the method in Chinese Pharmacopoeia(Volume Ⅲ,2010 edition). The absorbance of reference after incubation in 70 ℃ water bath for 20,40,60 and 120 min and in 80 ℃ water bath for 30 min were determined,based on which the reaction temperature and time were optimized. The optimized method was verified for linearity,reproducibility and accuracy. Results The residual deoxysodium cholate content in two batches of bulks of pneumococcal polysaccharide after incubation in 70 ℃ water bath for 20 min were determined,and the result showed recoveries of 8. 6% ~ 240. 8%,indicating that the suitability was unqualified. The condition for reaction was optimized as incubation in 80 ℃ water bath for 30 min. The deoxysodium cholate contents at a range of 10 ~ 80 μg / ml showed good linearity with the absorbances,with a R2 value of more than 0. 99. The CVs of determination results of three batches of references in reproducibility test were less than 8%. The recovery rates of deoxysodium cholate at low,moderate and high concentrations,added to 23 kinds of bulks of pneumococcal polysaccharide,were 80% ~ 120%.Conclusion The optimized method was simple,which showed good linearity,accuracy and reproducibility,and might be used for determination of residual deoxysodium cholate content in pneumococcal polysaccharide.
Publication Year: 2014
Publication Date: 2014-01-01
Language: en
Type: article
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