HPLC-RID法测定吸附无细胞百白破联合疫苗中甘油的残留量  

Determination of residual glycerol in adsorbed acellular DTP combined vaccine by HPLC-RID

作　　者：张雅军[1] 杨英超[1] 马霄[1] 肖新月[1] 吴先富[1] ZHANG Yajun;YANG Yingchao;MA Xiao;XIAO Xinyue;WU Xianfu(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药品标准》2022年第1期5-8,共4页Drug Standards of China

摘　　要：目的:建立高效液相色谱-示差折光(HPLC-RID)法测定吸附无细胞百白破联合疫苗中甘油残留量的方法,为其检测提供参考。方法:采用NH;色谱柱(250 mm×4.6 mm,5μm),以乙腈-水(85∶15)为流动相,柱温30℃,RID检测器温度35℃,流速1.0 mL·min^(-1)。结果:甘油在43.5~2 173.0μg·mL^(-1)浓度范围内呈良好的线性关系(R^(2)=1.000),平均回收率为99.98%,RSD为0.65%(n=9)。结论:该方法简便、准确,专属性强,可用于甘油残留量的测定,使产品质量更加有效地得到控制。Objective:To establish an HPLC-RID method for the determination of residual glycerol in adsorbed a-cellular DTP combined vaccine and to provide reference for the quality control.Methods:The test was performedin NH;column under the isocratic elution of acetonitrile-water(85∶15).The column temperature was 30℃,the RID detector temperature was 35℃and the flow rate was 1.0 mL·min^(-1).Results:The linear range of glycerolfell into 43.5-2173.0μg·mL^(-1)(R^(2)=1.000),and the average recovery was 99.98%with RSD as 0.65%(n=9).Conclusion:The method was convenient,accurate and specific.It can be used for the determination of glycerol residue in this vaccine,and helpful for the quality control of the product.

关 键 词：高效液相色谱-示差折光法 吸附无细胞百白破联合疫苗 甘油残留 

分 类 号：R921.2[医药卫生—药学]