妇炎康胶囊中违法添加诺氟沙星的检测

Determination of Norfloxacin IllegallyAdded into Fuyankang Capsule

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。

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.