Simultaneous determination of sucrose and mannitol by HPLC-ELSD in meningococcal polysaccharide vaccine
10.19778/j.chp.2025.04.014
- VernacularTitle:HPLC-ELSD法同时测定脑膜炎球菌多糖疫苗中蔗糖与甘露醇的含量
- Author:
Gang HE
1
;
Dongmei ZHOU
1
;
Yueyue LAI
1
;
Qian HUANG
1
;
Qian WANG
1
;
Siqin CAI
1
;
Gongxiao WANG
1
;
Fang HUANG
1
Author Information
1. 复星安特金(成都)生物制药有限公司研发中心,成都 610219
- Publication Type:Journal Article
- Keywords:
pharmaceutical excipient;
sucrose;
mannitol;
HPLC-ELSD;
content determination;
meningococcal polysaccharide vaccine
- From:
Drug Standards of China
2025;26(4):424-429
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a high performance liquid chromatography-evaporative light scattering detector(HPLC-ELSD)technique for simultaneous determining the content of excipients sucrose and mannitol in meningo-coccal polysaccharide vaccine.Methods:Using NanoChrom Sugar-10Ca analytical column(300 mm × 7.8 mm)and HPLC system(Agilent 1260).With purified water as the mobile phase,a flow rate of 0.5 mL·min-1,column temperature was 80 ℃,and the injection volume was 50 μL.The evaporative light detector was based on nitrogen.The carrier gas flow rate is 3.2 L·min-1,the temperature of drift tube was 1 10 ℃,the gain value was 1,and the impactor was"mode 1".This assay was subsequently validated for its system suitability,specificity,repeatability,intermediate precision and linearity,and accuracy.The established method was used to assay the contents of the sucrose and mannitol in four batches of meningococcal polysaccharide vaccine.Results:The estab-lished HPLC-ELSD method showed good systemic suitability.Specificity validation showed that there was no inter-ference peak in the blank solvent;the separation of the target peaks between sucrose and mannitol was＞2.0.The relative standard deviations(RSD)value of peak area of sucrose and mannitol in six tests were 0.44％and 0.38％,respectively.RSD of intermediate precision of both sucrose and mannitol were lower than 2.00％,indica-ting that the precision of high performance liquid chromatography instrument was well.The linear range of two excipients were 12.5-150.0 μg·mL-1(R2＞0.99,respectively).The recovery rate of sucrose and mannitol were 95.74％-99.33％,94.37％-98.85％,respectively.There was no significant difference in the contents of sucrose and mannitol in 4 batches of meningococcal polysaccharide vaccine.Conclusion:The HPLC-ELSD method showed good specificity,precision,linearity and accuracy,and the test results were stable and reliable,so that it is suitable for simultaneous determination of sucrose and mannitol contents of meningococcal polysaccharide injections.
