HPLC测定肺炎球菌多糖疫苗中的苯酚  

Determination of phenol content in Pneumococcal polysaccharide vaccine by HPLC

作　　者：武晗燕 李文东 赵璇 WU Hanyan;LI Wendong;ZHAO Xuan(Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Institute for Drug Control,Beijing,102206 P.R.China)

机构地区：[1]北京市药品检验研究院国家药品监督管理局仿制药研究与评价重点实验室、中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《华西药学杂志》2023年第3期329-331,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法测定肺炎球菌多糖疫苗中苯酚的含量。方法采用Capcell PAK C_(18)MGⅡ色谱柱(250 mm×4.6 mm,5μm),流动相为0.2 mol·L^(-1)硫酸盐缓冲液-乙腈(74:26),流速1.0 mL·min^(-1),检测波长270 nm,柱温30℃,进样量20μL,按峰面积外标法计算苯酚的含量。结果0.3183~1.5914×10^(3)μg·mL^(-1)苯酚与峰面积的线性关系良好(r=0.9999),定量限和检测限分别为0.064、0.0128 ng;9份加标供试品溶液的平均回收率为99.38%,RSD=0.61%。结论所用方法操作简便、准确、稳定性好、专属性强,可用于肺炎球菌多糖疫苗中苯酚的准确定量。OBJECTIVE To determine phenol content in Pneumococcal polysaccharide vaccine(PPV)by HPLC.METHODS The analysis was performed in Capcell PAK C_(18) MGⅡ(250 mm×4.6 mm,5μm).The mobile phase consisted sulfate buffer-acetonitrile(74:26)at a flow rate of 1.0 mL·min^(-1),the detection wavelength was set at 270 nm,of the column temperature was 30℃,and the sample loading was 20μL.Phenol content was calculated by external standard method of peak area.RESULTS A good linear relationship was obtained between the peak areas and the concentrations of phenol in the range from 0.3183-1.5914×103μg·mL^(-1)(r=0.9999),while the quantitative limit and detective limit were 0.064 ng and 0.0128 ng.The average recovery was 99.38%with the RSD of 0.61%(n=9).CONCLUSION The newly established method is simple,stable and reliable,which can be used for the quality control of phenol contents in PPV.

关 键 词：疫苗 肺炎球菌多糖疫苗 苯酚 抑菌剂 含量测定 高效液相色谱法 质量控制 标准提高 辅料 

分 类 号：R917[医药卫生—药物分析学]