离子对RP-HPLC法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评定

Uncertainty in the determination of metformin hydrochloride in compound metformin hydrochloride tablets by RP-Ion Pair HPLC

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.