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目的建立高效液相色谱法测定复方地米水杨酸酊中硝酸咪康唑的含量。方法色谱柱为Hypersil C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-甲醇-0.5%醋酸铵溶液(40∶40∶15),流速为1.0 mL·min-1,检测波长为220 nm,柱温为35℃。结果硝酸咪康唑在30.72~81.92μg·mL-1内与峰面积呈良好的线性关系(r=0.999 7);平均回收率为99.6%,RSD=0.68%(n=9)。结论本方法简便快速、准确、重复性好,可用于该制剂中硝酸咪康唑的含量测定。
Objective To establish a HPLC method for the determination of miconazole nitrate in compound dihydrate salicylic acid tincture. Methods The column was Hypersil C18 (250 mm × 4.6 mm, 5 μm) with acetonitrile-methanol-0.5% ammonium acetate solution (40:40:15) at a flow rate of 1.0 mL · min-1 and a detection wavelength of 220 nm, the column temperature is 35 ℃. Results The miconazole nitrate showed a good linear relationship with the peak area in the range of 30.72 ~ 81.92 μg · mL-1 (r = 0.999 7). The average recovery was 99.6% with RSD of 0.68% (n = 9). Conclusion The method is simple, rapid, accurate and reproducible. It can be used for the determination of miconazole nitrate in the preparation.