摘要
目的对奥美拉唑肠溶胶囊溶出度测定的不确定度进行分析和评价。方法高效液相色谱法测定奥美拉唑肠溶胶囊的溶出度,评定所得结果的不确定度。结果本实验方法测量结果的扩展不确定度U=4.4%(k=2),置信概率95%。结论分析并量化了检测方法的不确定度,为优化实验方法提供科学依据。
OBJECTIVE To evaluate uncertainty in dissolution test of omeprazole enteric-coated capsules.METHODS The dissolution of omeprazole enteric-coated capsules was determined by HPLC,and the uncertainty of the results was evaluated.RESULTS The extended uncertainty of measurement results of this method was U=4.4%(k=2),with confidence probability 95%.CONCLUSION Evaluation of the uncertainty can optimize the experiments,the more reliable result of the measurement could be obtained.
作者
韩志云
金鹏
滕海堂
王宣
HAN Zhi-yun;JIN Peng;TENG Hai-tang;WANG Xuan(Huaian Institute for Food and Drug Concrol,Huaian 223001,China)
出处
《海峡药学》
2020年第5期48-51,共4页
Strait Pharmaceutical Journal
