邓海清;尹珊珊;刘杨;张艳红;郝倩;高宇皎;任玉莹;殷建齐;邢盛宇;刘建凯;

• 1:北京民海生物科技有限公司研发中心

摘要(Abstract)：

目的建立检测吸附无细胞百白破联合疫苗(diphtheria,tetanus and acellular pertussis combined vaccine,DTa P)中2-苯氧乙醇含量的反相高效液相色谱法(RP-HPLC)。方法采用ZORBAX Eclipse XDB-C18色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈∶水(1∶1),流速1.0 m L/min,检测波长270 nm,柱温25℃,以外标法测定2-苯氧乙醇含量,并对该方法进行线性、重复性、中间精密度、准确度、专属性、耐用性验证。结果 2-苯氧乙醇浓度在100⁵00μg/m L范围内,与峰面积线性关系良好,R2大于0.99;3批供试品重复性试验2-苯氧乙醇含量相对标准偏差(RSD)分别为0.8%、0.4%和1.2%,中间精密度验证2-苯氧乙醇含量RSD分别为2.38%、2.36%和2.68%;准确度回收率在97.4%500μg/m L范围内,与峰面积线性关系良好,R2大于0.99;3批供试品重复性试验2-苯氧乙醇含量相对标准偏差(RSD)分别为0.8%、0.4%和1.2%,中间精密度验证2-苯氧乙醇含量RSD分别为2.38%、2.36%和2.68%;准确度回收率在97.4%¹01.9%之间;供试品中加入戊二醛和甲醛对2-苯氧乙醇含量的检测无干扰,专属性较好;温度变化对检测结果无显著影响,耐用性较好。结论该检测方法简单、快速、可靠,可用于疫苗中2-苯氧乙醇含量检测。

关键词(KeyWords)： 反相高效液相色谱法;吸附无细胞百白破联合疫苗;2-苯氧乙醇;含量测定

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 邓海清;尹珊珊;刘杨;张艳红;郝倩;高宇皎;任玉莹;殷建齐;邢盛宇;刘建凯;

DOI: 10.13200/j.cnki.cjb.002284

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