摘要
目的评定HPLC法测定盐酸左氧氟沙星胶囊含量的不确定度。方法通过建立H-PLC法测定含量的数学模型,分析测量过程,确定不确定度来源。利用统计学方法,对各量化的分量进行评定,找出影响不确定度的因素。结果 HPLC法测定盐酸左氧氟沙星胶囊含量的扩展不确定度为1.8%,测量结果表示为(100.4±1.8)%,k=2。结论 HPLC法测定盐酸左氧氟沙星胶囊含量的测量不确定度评估,方法简单合理,保证了测量结果准确可靠。
AIM To evaluate the measurement uncertainty for the content determination of levofloxacin hydrochloride capsules by HPLC. METHODS The mathematic model of HPLC quatitative method was established to identify the effeted factors of uncertainty and the influence of each factor on the results of detennirmtion was also evaluated. RESULTS The extended uncertainty for the HPLC determination of levofloxacin hydrochloride capsules was 1.8 %, the result of content determination was （ 100.4 ± 1.8） %, k = 2. CONCLUSION The evaluation method of measurement uncertainty for the content determination of levofloxacin hydrochloride capsules by HPLC is convenient and reasonable to guarantee the accurate and reliability of the results.
作者
邹燕
赵佳丽
欧贝丽
ZOU Yan ZHAO Jiali OU Beili(Zhejiang Jiaxing Institiute for Food and Drug Control, Jiaxing 314000, China)
出处
《中国临床药学杂志》
CAS
2016年第6期373-376,共4页
Chinese Journal of Clinical Pharmacy
关键词
测量不确定度
盐酸左氧氟沙星胶囊
含量测定
HPLC
measurement uncertainty
levofloxacin hydrochloride capsule
content determination
HPLC
