HPLC测定复方地米水杨酸酊中硝酸咪康唑的含量

Determination of Miconazole Nitrate in Compound Dexamethasone Acetate Salicylate Tincture by HPLC

摘要: 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，5 mm)，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30.72~81.92 μg·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。

Abstract: OBJECTIVE To establish an HPLC method to determine miconazole nitrate in compound dexamethasone acetate salicylate tincture. METHODS The analysis was carried out at 35 ℃ on a Hypersil C₁₈ column (250 mm×4.6 mm, 5 mm). The mobile phase consisted of acetonitrile-methanol-0.5% ammonium acetate solution (40∶40∶15) with the flow rate of 1.0 mL·min^-1. The detection wavelength was 220 nm. The column temperature was 35 ℃. RESULTS The calibration curve of miconazole nitrate was linear over the range of 30.72-81.92 μg·mL^-1(r=0.999 7). The average recovery was 99.6% (RSD=0.68%, n=9). CONCLUSION This method is simple, accurate, reproducible and applicable for the content determination of miconazole nitrate in compound dexamethasone acetate salicylate tincture.