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.
作者
李潇
郭雷
游畅
白亦昊
邵天舒
张建敏
王静
郜昭慧
丁锐
周长明
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)
出处
《中国药业》
CAS
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]。
关键词
甲氧基苯胺值
注射用前列地尔
破乳
测定方法
anisidine value
Alprostadil Dried Emulsion for Injection
demulsification
determination method
