ELSD-HPLC法测定重组人干扰素α2b注射液中的泊洛沙姆188  

Determination of Poloxamer 188 in Recombinant Human Interferonα2b Injection by ELSD-HPLC

作　　者：滕宝霞 俞露 牟建平 刘景会 贺晓文 TENG Baoxia;YU Lu;MU Jianping;LIU Jinghui;HE Xiaowen(Gansu Institute for Drug Control,Lanzhou 730060;Cytokine Room,Changchun Institute of Biological Products Co.,Ltd.,Changchun 130000)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730060 [2]长春生物制品研究所有限责任公司细胞因子室,吉林长春130000

出　　处：《中国医药工业杂志》2022年第5期716-719,共4页Chinese Journal of Pharmaceuticals

摘　　要：建立了蒸发光散射检测器-高效液相色谱(ELSD-HPLC)法测定重组人干扰素α2b(1)注射液中泊洛沙姆188(2)的含量。色谱柱采用球状亲水硅胶TSKgel G3000SW柱(7.5 mm×600 mm,10μm),以水∶乙腈(75∶25)为流动相,等度洗脱。流速为0.6 ml/min,漂移管温度为105℃,载气流量为3.0 L/min。结果显示,2在0.1~1.25 mg/ml内线性关系良好。2的平均回收率(n=9)为101.2%,RSD为0.5%。建立的方法专属性强,可用于1注射液中2含量的测定。An evaporative light scattering detector-high performance liquid chromatography(ELSD-HPLC)method was established to determine the content of poloxamer 188(2)in recombinant human interferonα2b(1)injection.The spherical hydrophilic silica gel TSKgel G3000SW column(7.5 mm×600 mm,10μm)was used with water∶acetonitrile(75∶25)as mobile phase(isocratic elution).The flow rate was 0.6 ml/min,the drift tube temperature was 105℃,and the carrier gas flow was 3.0 L/min.The results showed that it was linear for 2 in the range of 0.1-1.25 mg/ml.The average recovery(n=9)of 2 was 101.2%,with the RSD of 0.5%.The established method is highly specific,which can be used for the determination of 2 in 1 injection.

关 键 词：重组人干扰素α2b注射液 泊洛沙姆188 药用辅料 蒸发光散射 凝胶色谱 

分 类 号：R917[医药卫生—药物分析学]