诺氟沙星胶囊含量测定的不确定度及Z比分数研究

Study on the Uncertainty and the Z Score for the Assay of Norfloxacin Capsules

目的比较、分析诺氟沙星胶囊含量测定的不确定度及Z比分数法。方法按照《中国药典》2020年版诺氟沙星胶囊项下的方法测定含量。考察各影响因素,计算不确定度,取包含因子k=2(对应的置信水平为95%),得扩展不确定度。用Z比分数法统计参加此次能力验证的233家实验室的结果。结果测得考核样诺氟沙星胶囊含量为102.2%,扩展不确定度为1.44%;Z比分数法统计Z值为0.9,结果满意。结论通过2种方法的比较,可以对高效液相色谱法含量测定有更全面的认识。

OBJECTIVE To compare and analyze the uncertainty and the Z score for the assay of Norfloxacin Capsules.METHODS To confirm the assay of Norfloxacin Capsules by Ch.P 2020 Vol,the factors influenced upon the measurement were inspected and the uncertainty of each factor was calculated,then the expanded uncertainty was obtained by using a coverage factor k=2(confidence of approximately 95%).Analyzed the results of 233 labs participating in this proficiency testing by the use of the Z score.RESULTS The assay of Norfloxacin Capsules was 102.2%,Expanded uncertainty was 1.44%.The statistical results of the Z score were satisfying.CONCLUSION Through the comparison of the two methods,more comprehensive knowledge of the content determination of HPLC can be get.