HPLC同时测定MF59佐剂中的聚山梨酯80和三油酸山梨坦  

Simultaneous determination of polysorbate 80 and sorbitan trioleate in MF59 adjuvant by HPLC

作　　者：蒋佳兴 张姮婕 唐瑶 龙丽娟 马晶 李炎 杨蕾 王觉晓 JIANG Jiaxing;ZHANG Hengjie;TANG Yao;LONG Lijuan;MA Jing;LI Yan;YANG Lei;WANG Juexiao(SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products,NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products,Sichuan Institute for Drug Control,Chengdu,Sichuan,611731 P.R.China)

机构地区：[1]四川省药品检验研究院,国家药品监督管理局疫苗及生物制品质量控制与评价重点实验室,四川省药品监督管理局生物制品质量监测与风险评估重点实验室,四川成都611731

出　　处：《华西药学杂志》2025年第2期189-192,共4页West China Journal of Pharmaceutical Sciences

基　　金：成都市科技项目(2019-YF08-00308-GX);四川省药品监督管理局科技计划项目(2022001)。

摘　　要：目的采用高效液相色谱-蒸发光散射检测法(HPLC-ELSD)同时测定MF59佐剂中聚山梨酯80和三油酸山梨坦的含量。方法采用反相离子交换色谱柱ChromCore~(TM)sAA(150 mm×4.6 mm,5μm),流动相为0.1%乙酸水溶液-0.1%乙酸异丙醇溶液,梯度洗脱,进样量为2μL,柱温为40℃,流速为1.2 mL·min^(-1)。结果0.5136~5.1358 mg·mL^(-1)聚山梨酯80与峰面积呈良好的线性关系(r^(2)=0.9999),平均回收率为98.40%,RSD=3.80%(n=6);三油酸山梨坦0.5028~5.0278 mg·mL^(-1)与峰面积呈良好的线性关系(r^(2)=0.9998),平均回收率为98.30%,RSD=2.70%(n=6)。结论所用方法操作简便,选择性好,适用于MF59佐剂中聚山梨酯80和三油酸山梨坦的含量测定。OBJECTIVE To simultaneous determine of polysorbate 80 and sorbitan trioleate in MF59 adjuvant by HPLC-ELSD.METHODS The separation was performed on ChromCoreTM sAA(150 mm×4.6 mm,5μm).The mobile phase consisted of 0.1%acetic acid water and 0.1%acetic acid isopropanol with gradient elution.The inject volume was 2μL.The column temperature was 40℃.The flow rate was 1.2 mL·min^(-1).RESULTS Polysorbate 80 have good linear relationships in the concentration of 0.5136-5.1358 mg·mL^(-1)(r^(2)=0.9999).The average recovery was 98.40%with the RSD of 3.80%(n=6).Sorbitan trioleate have good linear relationships in the concentration of 0.5028-5.0278 mg·mL^(-1)(r^(2)=0.9998).The average recovery was 98.30%with the RSD of 2.70%(n=6).CONCLUSION The method was times-saving and alternative.It was suitable for the determination of polysorbate 80 and sorbitan trioleate in MF59 adjuvant.

关 键 词：MF59佐剂 聚山梨酯80 三油酸山梨坦 高效液相色谱 蒸发光散射检测法 含量测定 同时测定 

分 类 号：R917[医药卫生—药物分析学]