高效液相色谱法测定甲硝唑乳膏中甲硝唑的含量

Determination of metronidazole in metronidazole cream by HPLC

目的建立高效液相色谱法测定医院制剂甲硝唑乳膏中甲硝唑的含量。方法色谱柱为Hy-persil BDS-C18(250 mm×4.6 mm,5μm);流动相为甲醇-水(20∶80);流速为1.0 mL/min;检测波长为320 nm;柱温为30℃;进样体积为20μL。结果甲硝唑在5.02～40.16μg/mL(r=0.999 9)范围内线性关系良好,平均回收率(n=9)为98.2%(RSD=2.5%)。结论本方法操作简便、结果准确,可作为甲硝唑乳膏的质量控制方法。

Objective To establish an HPLC method for determining the metronidazole in metronidazole cream.Methods The analytical column was Hypersil BDS-C18（250 mm×4.6 mm,5 μm）,the mobile phase was methanol-water（20∶ 80）at the flow rate of 1.0 mL/min at 30 ℃.Detection wavelength was set at 320 nm,and the incoming sample amount was 20 μL.Results The linear range of metronidazole was 5.02~40.16 μg/mL,r=0.999 9,the average recovery rate（n=9）was 98.2%,RSD was 2.5%.Conclusion This method is accurate and reliable,it can be used for the quality control of metronidazole cream.