HPLC法测定重组人干扰素α2b注射液中吐温80的含量  

Determination of Tween 80 content in recombinant human interferon α2b injection by HPLC

作　　者：赵辉[1,2] 李增礼[2] 周乐春[2] 储成风[2] 倪晓燕[2] 王荣海[1,2] 宋礼华[1,2] 

机构地区：[1]安徽省生物研究所,合肥230088 [2]安徽安科生物工程集团股份有限公司,合肥230088

出　　处：《中国生物制品学杂志》2012年第5期623-624,629,共3页Chinese Journal of Biologicals

基　　金：国家"重大新药创制"科技重大专项(2008ZX09203-003)

摘　　要：目的采用HPLC法测定重组人干扰素α2b注射液中吐温80的含量。方法按设置的色谱条件对检测重组人干扰素α2b注射液中吐温80含量的HPLC方法进行专属性验证、系统适应性验证、线性范围测定、实验内重复性验证、日间重复性验证、最低检测限测定、准确性验证,并对3批重组人干扰素α2b注射液中吐温80的含量进行检测。结果该测定方法具有专属性;系统适应性良好;线性范围为0.031 25～2.5 mg/ml,R2=0.999 7,线性关系良好;实验内重复性,峰面积和浓度的RSD值分别为0.71%和0.56%;日间重复性,保留时间和峰面积的RSD值分别为0.47%和2.76%;最低检测限为10 mg/L;加样回收率分别为101.99%、99.96%和102.2%,RSD=1.16%;3批人干扰素α2b注射液中吐温80的相对含量分别为0.940、0.936和0.950 mg/ml,分别为标示量的94.0%、93.6%和95.0%。结论本方法准确、快速、可靠,可用于重组人干扰素α2b注射液中吐温80含量的测定。Objective To determine the Tween 80 content in recombinant human interferon α2b injection by HPLC. Methods Under designed condition, HPLC was verified for specificity, systemic suitability, intra- and inter-reproducibility and accuracy, and determined for linear range and minimum detection limit. The Tween 80 contents in three batches of recombinant human interferon α2b injection were determined by HPLC method. Results The HPLC method showed good specificity, suitability and linearity （R2 = 0. 999 8）, of which the linear range was 0. 031 25 - 2. 5 mg / ml. In intra-reproducibility test, the RSDs of peak area and concen- tration were 0. 71% and 0. 56% respectively. In inter-reproducibility test, the RSDs of retention time and peak area were 0. 47% and 2. 76%respectively. The recovery rates of three batches of samples loaded were 101. 990/0,99.96% and 102. 2% respectively, with a RSD of 1. 16%. The Tween 80 contents in three batches of interferon a2b injection were 0. 940,0. 936 and 0. 950 mg/ml, which were 94. 0% ,93. 6% and 95. 0% of stated amounts, respectively. Conclusion HPLC method was accurate, rapid and reliable, which might be used for determination of Tween 80 content in recombinant human interferon α2b injection.

关 键 词：色谱法 高压液相 聚山梨醇酯类 干扰素Α2B 

分 类 号：O652.63[理学—分析化学] R392.33[理学—化学]