摘要
通过对高效液相色谱法(HPLC)测定富马酸酮替芬片含量均匀度的方法进行不确定度分析,建立数学模型,量化不确定度分量,计算出扩展不确定度[U HPLC=0.64%(k=2)]。分析结果表明,电子天平的使用和稀释步骤是产生不确定的主要来源。从该模型中能找到更好控制实验误差的方法。根据扩展不确定度的大小也可以为富马酸酮替芬片含量均匀度测定方法的选择提供参考依据。
To evaluate uncertainty of HPLC methods for content uniformity of ketotifen fumarate tablets,the corresponding mathematical modelwas established,and the uncertain componentswere quantified.The expanded uncertainty[U HPLC=0.64%(k=2)]were calculated.Theanalysis results showed that the uncertaintyof ketotifen fumarate tablets by HPLC was mainly caused by electronic balance and dilution step.From this model,a better way to control the experimental errorcan be found.The expanded uncertainty can also provide a reference for the selection of the content uniformity method of ketotifen fumarate tablets.
作者
王萍
李佳
金华
WANG Ping;LI Jia;JIN Hua(Huai'an Institute for Food and Drug Control,Jiangsu Huai'an 223002,China)
出处
《广州化工》
CAS
2021年第13期113-115,共3页
GuangZhou Chemical Industry
