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作 者:汪明志 WANG Ming-zhi(Suzhou Institute For Drug Control,Suzhou 215104,China)
机构地区:[1]苏州市药品检验检测研究中心
出 处:《海峡药学》2019年第8期103-105,共3页Strait Pharmaceutical Journal
摘 要:目的反相-高效液相色谱法测定维C银翘片中对乙酰氨基酚的不确定度。方法建立反相高效液相色谱法测定对乙酰氨基酚的数学模型,量化分析各因素对测量不确定度的影响,计算出标准测量不确定度及扩展不确定度。结果反相-高效液相色谱法测定维C银翘片中对乙酰氨基酚含量的扩展不确定为2.8%,测量结果表示为(99.7%±2.8%),k=2。结论平均片重和称样量对本次测量不确定度影响较大,实验结果为该制剂的生产和含量测定提供参考依据。OBJECTIVE To determine the uncertainty of acetaminophen in Wei C YinQiao tablets by RP-HPLC. METHODS A Mathematical Model for the determination of uncertainty of acetaminophen by RP-HPLC was established.Various factors were analysed on uncertainty of measurement.The standard uncertainty of measurement and the extended uncertainty were calculated. RESULTS The extended uncertainty of acetaminophen in Wei C YinQiao tablets by RP-HPLC was 2.8%,and the resulting determination was expressed as (99.7%±2.8%)(k=2). CONCLUSION The average tablet weight and the weight of the sample had great influence on the uncertainty.The experimental results provided a reference for the production and content determination of the preparation.
关 键 词:对乙酰氨基酚 不确定度 维C银翘片片 反相-高效液相色谱法
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