摘要
目的建立测定重组人胰岛素注射液中异天冬氨酸(isoAsp)含量的方法。方法应用IsoQuant^(■)异天冬氨酸检测试剂盒,结合高效液相色谱法检测重组人胰岛素注射液中isoAsp的含量,同时按2020年版《中国药典(三部)》法定标准测定杂质A_(21)脱氨人胰岛素。结果S-腺苷-L-高半胱氨酸(SAH)进样量在5~100 pmol范围内与峰面积线性关系良好(R^(2)=0.9997),SAH平均加样回收率为101.68%,RSD为11.60%(n=9);2批样品中isoAsp含量的平均值分别为3.46 nmol/L和2.78 nmol/mL,杂质A_(21)脱氨人胰岛素的含量分别为1.04 nmol/mL和1.70 nmol/mL。结论所建立的方法可有效测定重组人胰岛素注射液中isoAsp的含量,可作为法定标准中杂质A_(21)脱氨人胰岛素检验的补充,以控制重组人胰岛素注射液的质量。
Objective To establish a method for the determination of isoaspartic acid(isoAsp)in Recombinant Human Insulin Injection.Method An IsoQuant^(■)isoAsp detection kit was used to determine the content of isoAsp in Recombinant Human Insulin Injection by the high-performance liquid chromatography(HPLC)method,and the impurity A_(21)desamido human insulin was determined according to the legal standard of the Chinese Pharmacopoeia(2020 Edition,VolumeⅢ).Results The injection amount of S-adenosyl-L-homocysteine(SAH)had a good linear relationship with the peak area in the range of 5-100 pmol(R^(2)=0.9997).The average recovery of SAH was 101.68%with an RSD of 11.60%(n=9).The average content of isoAsp in the two batches of samples was 3.46 nmol/L and 2.78 nmol/mL,and the content of impurity A_(21)desamido human insulin was 1.04 nmol/mL and 1.70 nmol/mL.Conclusion The established method can effectively determine the content of isoAsp in Recombinant Human Insulin Injection,which can be used as a supplement to the determination of impurity A_(21)desamido human insulin in the legal standard to control the quality of Recombinant Human Insulin Injection.
作者
李恒
晏菊姣
范晓磊
宋德芳
吴健鸿
周朝晖
LI Heng;YAN Jujiao;FAN Xiaolei;SONG Defang;WU Jianhong;Zhaohui Sunny ZHOU(Wuhan Institute for Drug and Medical Device Control,Wuhan,Hubei,China 430075;Department of Chemistry and Chemical Biology·Barnett Institute of Chemical and Biological Analysis,Northeastern University,Boston,Massachusetts,USA 02115)
出处
《中国药业》
CAS
2022年第9期90-93,共4页
China Pharmaceuticals
基金
湖北省武汉市第五批“黄鹤英才计划”[2017]
湖北省食品药品监督管理局科研项目[201801013]。
