| HPLC-外标法测定奥沙利铂甘露醇注射液中奥沙利铂含量的不确定度分析 |
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| 引用本文： | 孔令艳,孙秀春,韩靖懿. HPLC-外标法测定奥沙利铂甘露醇注射液中奥沙利铂含量的不确定度分析[J]. 齐鲁药事, 2012, 31(5): 279-280 |
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| 作者姓名： | 孔令艳 孙秀春 韩靖懿 |
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| 作者单位： | 1. 辰欣药业股份有限公司,山东,济宁,272073
2. 泰山医学院,山东,泰安,271016 |
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| 摘 要： | 目的评定以高效液相色谱-外标法测定奥沙利铂甘露醇注射液中奥沙利铂含量的不确定度。方法根据《测量不确定度评定与表示》(JJFI059-1999)中有关规定,对奥沙利铂甘露醇注射液中奥沙利铂的含量测定进行不确定度评定。结果扩展不确定度为1.14%,含量测定结果可表示为(95.9±1.2)%。不确定度主要来源为天平的称量和溶液的稀释,其次为操作过程中的随机效应。结论选择检定合格的仪器,提高操作技能,可有效减小实验的不确定度。
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| 关 键 词： | 高效液相色谱-外标法 奥沙利铂 含量测定 不确定度分析 |
Uncertainty analysis of the determination of oxaliplatin in Oxaliplatin and Mannitol Injection by HPLC-external standard method |
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| KONG Ling-yan , SUN Xiu-chun , HAN Jing-yi. Uncertainty analysis of the determination of oxaliplatin in Oxaliplatin and Mannitol Injection by HPLC-external standard method[J]. qilu pharmaceutical affairs, 2012, 31(5): 279-280 |
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| Authors: | KONG Ling-yan SUN Xiu-chun HAN Jing-yi |
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| Affiliation: | 1.Cisen Pharmaceutical Co.,Ltd.,Jining 272073,China;2.Taishan Medical University,Taian 271016,China) |
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| Abstract: | Objective To evaluate the uncertainty of the determination of oxaliplatin in Oxaliplatin and Mannitol Injection by HPLC-external standard method.Methods According to the relevant provisions in Evaluation and Expression of Uncertainty in Measurement(JJFI059-1999),the uncertainty of the determination of oxaliplatin in the Oxaliplatin and Mannitol Injection was evaluted.Results The expanded uncertainty was 1.14% and the determination results can be expressed as(95.9±1.2)%.The main source of the uncertainty were the balance weighing and the dilution of solution,followed by the random effects in the operation.Conclusion The selection of certified apparatus and improvement of operating skills can effectively reduce the uncertainty. |
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| Keywords: | HPLC-external standard method Oxaliplatin Determination Uncertainty analysis |
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