摘要
目的:评定离子对反相高效液相色谱法(RP-HPLC)测定复方盐酸二甲双胍片中盐酸二甲双胍含量的不确定度。方法:建立数学模型,识别不确定度来源,计算各不确定度分量和合成不确定度,得出扩展不确定度。结果:盐酸二甲双胍含量为(98.51±2.48)%。不确定度主要来源于标准溶液的配制。结论:此不确定度评定方法适用于RP-HPLC测定复方盐酸二甲双胍片中盐酸二甲双胍含量时的不确定度评定,可为优化实验方法提供科学依据,提高测定过程的质控水平。
Objective:To assess the uncertainty in the determination of metformin hydrochloride in compound metformin hyd-rochloride tablets by RP-Ion Pair HPLC. Methods:A mathematical model was established and the sources of uncertainty were identified. Then the individual component of uncertainty was evaluated. Finally the combined uncertainty and the extended uncertainty were calculated. Results:The metformin hydrochloride in compound metformin hydrochloride tablets was(98.51±2.48)%.The uncertainty was mainly due to the configuration of standard solution. Conclusions:The established analytical method may be used in uncertainty assessment of metformin hydrochloride content determination by RP-Ion Pair HPLC.
作者
邓丰
Deng Feng(Fujian Testing Institute of Quality for Food and Drug,Fuzhou 350001 China)
出处
《甘肃医药》
2018年第8期681-684,共4页
Gansu Medical Journal