HPLC法测定硝酸咪康唑栓中硝酸咪康唑的含量

目的建立硝酸咪康唑栓的HPLC含量测定方法。方法采用HPLC法,色谱条件:ODS柱(250mm×4.6mm,5μm);甲醇-乙腈-5g.L-1醋酸铵溶液(42.5∶42.5∶15)为流动相;流速1.0mL.min-1;检测波长230nm;进样量10μL;柱温35℃。结果硝酸咪康唑进样量在0.499～2.994mg.mL-1范围内,其峰面积值与进样质量浓度有良好的线性关系,r=0.999 1,回收率为100.7%,RSD为1.0%(n=3)。结论经与紫外-可见分光光度法比较,该法重复性好,灵敏度高,结果准确,适用于硝酸咪康唑栓的含量测定。

HPLC determination of miconazole nitrate content of Miconazole Nitrate Suppositories

Objective To establish an HPLC method for Miconazole Nitrate Suppositories.Method Chromatography conditions were as follows:ODS column(250 mm × 4.6 mm,5 μm);methanol-acetonitrile-5 g·L-1 ammonium acetate solution(42.5∶42.5∶15) as mobile phase;flow rate of 1.0 mL·min-1;detection wavelength of 230 nm;injection volume 10 μL;column temperature 35 ℃.Results Within the miconazole nitrate injection amount of 0.499-2.994 mg·mL-1,the peak area values and sample concentration showed a good linear relationship,r=0.999 1.The recovery was 100.7% with RSD of 1.0%(n=3).Conclusion Compared with the UV-visible spectrophotometry,the method has good reproducibility and high sensitivity.The method is accurate,and is suitable for the determination of Miconazole Nitrate Suppository.