| HPLC-RID法测定吸附无细胞百白破联合疫苗中甘油的残留量 |
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| 引用本文： | 张雅军,杨英超,马霄,肖新月,吴先富. HPLC-RID法测定吸附无细胞百白破联合疫苗中甘油的残留量[J]. 中国药品标准, 2022, 23(1): 5-8 |
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| 作者姓名： | 张雅军 杨英超 马霄 肖新月 吴先富 |
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| 作者单位： | 中国食品药品检定研究院 |
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| 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NH2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43.5～2173.0μg...
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| 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 |
Determination of residual glycerol in adsorbed acellular DTP combined vaccine by HPLC-RID |
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| ZHANG Yajun,YANG Yingchao,MA Xiao,XIAO Xinyue,WU Xianfu. Determination of residual glycerol in adsorbed acellular DTP combined vaccine by HPLC-RID[J]. , 2022, 23(1): 5-8 |
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| Authors: | ZHANG Yajun YANG Yingchao MA Xiao XIAO Xinyue WU Xianfu |
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| Affiliation: | (National Institutes for Food and Drug Control,Beijing 102629,China) |
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| Abstract: | 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(R2=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. |
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| Keywords: | HPLC-RID diphtheria tetanus and acellular pertussis combined vaccine adsorbed glycerol residue |
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