Establishment and verification of ion chromatography for determination of multi-ion content in inactivated poliomyelitis vaccine
10.13200/j.cnki.cjb.004449
- VernacularTitle:脊髓灰质炎灭活疫苗中多离子含量离子色谱检测方法的建立及验证
- Author:
SU Wen
- Publication Type:Journal Article
- Keywords:
Ion chromatography;
Inactivated poliomyelitis vaccine(IPV);
Multi-ions
- From:
Chinese Journal of Biologicals
2025;38(03):344-351+358
- CountryChina
- Language:Chinese
-
Abstract:
Objective To determine the multi-ion content in inactivated poliomyelitis vaccine(IPV) by using ion chromatography,and to verify and preliminarily apply the method,so as to perform quality control for multi-ions in the vaccines.Methods Chromatographic conditions:anion exchange analysis column(4 mm × 250 mm) with the sample loading of 25 μL,isocratic elution with 30 mmol/L potassium hydroxide eluent at the flow rate of 1.0 mL/min and column temperature of 25℃,and detection by a conductivity detector for 15 min of detection time.Chromeleon chromatography workstation was used to record and analyze the data.The applicability,specificity,linearity,accuracy and reproducibility of the established method were verified,and the limit of detection(LOD) and limit of quantitation(LOQ) were determined.Ten batches of IPV made from Sabin strains(sIPV) were detected by using the established method.Results The relative standard deviations(RSDs) of peak areas of fluoride ions,chloride ions,sulfate ions,nitrate ions and phosphate ions were all less than 2.0% after 8 consecutive injections;The method showed strong specificity in detecting chloride ions,fluoride ions,nitrate ions,phosphate ions and sulfate ions.In the range of 2.5-150 μg/mL,there was a good linear relationship between the above ion concentration and the chromatography peak area,with all the r~2 values of more than 0.995.Adding low(10 μg/mL),medium(25 μg/mL)and high(50 μg/mL) concentrations of multi-ion mixed standard solution to sIPV filtrate,the recovery rates were between93.69% and 106.70%,and the RSDs were within 0.05%-0.7% in six tests.The minimum LODs of fluoride ion,chloride ion,sulfate ion,nitrate ion and phosphate ion were 8.3,2.5,5.1,0.025 and 0.021 μg/mL,and the minimum LOQs were 0.025,8.3,0.025,0.45 and 0.063 μg/mL,respectively.Fluoride ion,sulfate ion and nitrate ion were not detected in 10batches of sIPV using the established method,while chloride ion and phosphate ion were detected.Conclusion Ion chromatography is an effective detection method for the determination of multi-ion concentration changes in IPV,which is simple,rapid,sensitive and reproducible,and can help enterprises to control the quality of this kind of vaccines
