To compare the difference between the Chinese pharmacopoeia (edition 2015) method (Method 1) and European pharmacopoeia 8.0 method (Method 2) for the detection of phosphorus content in group A meningococcal polysaccharide vaccine (MenAPSV), so as to provide reference for the selection and further optimization of methods in the future.

The phosphorus contents in the standard solution and MenAPSV were detected. The differences of standard curve, limit of quantitation, accuracy, precision and durability (solution stability) of these 2 methods were compared.

The average determination coefficients of standard curve were 0.997 3 for Method 1 and 0.999 3 for Method 2, and the limits of quantitation were 3.97 μg for Method 1 and 2.16 μg for Method 2. The phosphorus content in MenAPSV detected by these 2 methods showed that the relative standard deviations of detection results were 10.3% for Method 1 and 7.6% for Method 2, and the phosphorus adding recovery rates of Method 1 and Method 2 were 87.8%-113.1% and 97.1%-103.6%, respectively. The colorimetric analysis was started after the solution was placed for 0, 30 and 60 min, respectively. The absorbance increasing values per 30 min were 0.059 for Method 1 and 0.003 for Method 2.

Both methods can be applied to detect the phosphorus content in MenAPSV. Compared with Method 1, Method 2 has better linearity, lower detection quantitation limit, higher accuracy and precision, and better durability (solution stability).

Neisseria meningitidis, serogroup A; Polysaccharides, bacterial; Meningococcal vaccines; Phosphorus