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目的:建立高效液相色谱法同时测定白芍总苷中的芍药苷和芍药内酯苷的不确定度评定方法。方法:采用高效液相色谱法测定芍药苷和芍药内酯苷含量,分析影响其不确定度的因素来源,对各个不确定度因素进行评定,并计算合成不确定度,最终给出测量结果的扩展不确定度和置信水平。结果:不确定度评估芍药苷为±1.48%、芍药内酯苷为±0.66%。结论:方法可用于高效液相色谱法测定药物含量的不确定度分析,使测定结果更加可靠。
OBJECTIVE: To establish an HPLC method for simultaneous determination of paeoniflorin and paeoniflorin in total glucosides of paeony as assessment uncertainty. Methods: The content of paeoniflorin and paeoniflorin in paeoniflorin and paeoniflorin were determined by high performance liquid chromatography (HPLC), the sources of the factors influencing their uncertainty were analyzed, the factors of each uncertainty were evaluated, the uncertainty of synthesis was calculated, and the result of measurement Expand uncertainty and confidence levels. Results: The uncertainty was evaluated as ± 1.48% for paeoniflorin and ± 0.66% for paeoniflorin. Conclusion: The method can be used for the determination of drug content by high performance liquid chromatography uncertainty analysis, the determination of the results more reliable.