注射用前列地尔干乳剂中甲氧基苯胺值测定方法的建立  

Establishment of a Method for Determination of Anisidine Value in Alprostadil Dried Emulsion for Injection

作　　者：李潇 郭雷[1] 游畅 白亦昊[1] 邵天舒[1] 张建敏 王静[1] 郜昭慧 丁锐[1] 周长明[1] LI Xiao;GUO Lei;YOU Chang;BAI Yihao;SHAO Tianshu;ZHANG Jianmin;WANG Jing;GAO Zhaohui;DING Rui;ZHOU Changming(Beijing Institute for Drug Control·NMPA Key Laboratory for Research and Evaluation of Generic Drugs·Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing,China 102206)

机构地区：[1]北京市药品检验所·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：《中国药业》2021年第10期51-53,共3页China Pharmaceuticals

基　　金：国家药典委员会药品标准提高项目[341]。

摘　　要：目的建立注射用前列地尔干乳剂中甲氧基苯胺值的测定方法。方法样品以三氟乙酸破乳,用异辛烷溶解,60℃下水浴旋蒸15 min;残渣以异丙醇-异辛烷(2∶8,V/V)溶解,与4-甲氧基苯胺反应,于350 nm波长处测定吸光度,并计算甲氧基苯胺值。结果甲氧基苯胺质量浓度在0.6~2.4μg/m L范围内与吸光度线性关系良好,检测限为0.2μg/m L,耐用性试验的RSD为4.67%(n=5)。结论所建立的方法操作简便、准确,可用于注射用前列地尔干乳剂中甲氧基苯胺值的测定。Objective To establish a method for the determination of anisidine value in Alprostadil Dried Emulsion for Injection.Methods The sample was demulsified by adding trifluoroacetic acid,dissolved with isooctane,and rotary evaporated in a water bath at60℃for 15 min.The residue was dissolved with isopropanol-isooctane(2∶8,V/V)and reacted with 4-methoxyaniline.The absorbance was measured at 350 nm and the anisidine value was calculated.Results The linear range of anisidine was 0.6-2.4μg/mL,the limit of detection(LOD)was 0.2μg/m L.The RSD of the durability test was 4.67%(n=5).Conclusion The method is simple and accurate,which can be used for the determination of anisidine value in Alprostadil Dried Emulsion for Injection.

关 键 词：甲氧基苯胺值 注射用前列地尔 破乳 测定方法 

分 类 号：R917[医药卫生—药物分析学]