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妇炎康胶囊中违法添加诺氟沙星的检测
引用本文:闵春艳,缪刚,许奇. 妇炎康胶囊中违法添加诺氟沙星的检测[J]. 抗感染药学, 2010, 7(3): 187-190. DOI: 10.3969/j.issn.1672-7878.2010.03-013
作者姓名:闵春艳  缪刚  许奇
作者单位:苏州药品检验所,江苏,苏州,215002
摘    要:目的:建立妇炎康胶囊中违法添加诺氟沙星的检测方法。方法:采用高效液相色谱结合二级管阵列紫外光谱检测,色谱柱C18(4.6mm×250mm,5μm);流动相为0.025mol/L甲酸溶液(以三乙胺调节pH至3.0±0.1)-乙腈(90∶10);流速为1mL/min;柱温为35℃;进样体积为10μL;检测波长为278nm。结果:结合高效液相色谱保留时间、紫外光谱等信息分析得出"妇炎康胶囊"中非法添加诺氟沙星。诺氟沙星在1.156~23.12μ/gmL范围内呈良好的线性关系,r=0.9992;检测限为1ng;加样平均回收率为103.51%,RSD为1.15%(n=6),每粒"妇炎康胶囊"中含诺氟沙星量为3.30mg。结论:本方法操作简便、准确、可靠,可用于检测妇炎康胶囊中违法添加诺氟沙星的定性和定量。

关 键 词:妇炎康胶囊  诺氟沙星  高效液相色谱法

Determination of Norfloxacin Illegally Added into Fuyankang Capsule
MIN Chun-yan,MIAO Gang,XU Qi. Determination of Norfloxacin Illegally Added into Fuyankang Capsule[J]. Anti-infection Pharmacy, 2010, 7(3): 187-190. DOI: 10.3969/j.issn.1672-7878.2010.03-013
Authors:MIN Chun-yan  MIAO Gang  XU Qi
Affiliation:Jiangsu Suzhou Institute for Drug Control,Suzhou Jiangsu 215002,China
Abstract:Objective:To establish a method for detecting norfloxacin illegally added into Fuyankang capsule.Methods:The seperation of norfloxacin was performed on C18 column with column temperature set at 35 ℃,the mobile phase was composed of acetonitrile and 0.025 mol/L formic acid solution which was adjusted to pH 3.0±0.1(10:90)by triethylamine with a flow rate at 1 mL/min.The injection volume was 10 μL.The detection wavelength was at 278 nm.Results:It has been proved that there was norfloxacin mixxed in Fuyankang capsule based on the data of retention time of HPLC including ultraviolet spectra.The linear range of norfloxacin was 1.156~23.12 μ/mL for g assay,r = 0.999 2;the detection limit was 1 ng.The average recovery was 103.50%,RSD was 1.15%(n = 6)and each Fuyankang capsule containing norfloxacin of 3.30 mg.Conclusion:The method was simple,accurate and reliable.It can be used to detect norfloxacin illegally added into Fuyankang capsule accurately.
Keywords:Fuyankang capsule  norfloxacin  HPLC
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