高效液相色谱法测定复方咪康唑洗剂中硝酸咪康唑含量

摘要

Objective To establish an HPLC method to determine miconazole nitrate in compound miconazole nitrate lotion. Methods The analysis was carried out at 30 ℃ on a Eclipse C18 column ( 250 mm × 4. 6 mm, 5 μm ) . The mobile phase consisted of methanol-0. 5% ammonium acetate solution ( 20:80 ) with the flow rate of 1. 0 mL/min. The detection wavelength was 235 nm. The column tem-perature was 30 ℃. Results The calibration curve of miconazole nitrate was linear over the range of 0-2. 106 0 g/L ( r=0. 999 3 ) . The average recovery was 98. 98% ( RSD=1. 91%, n=9 ) . Conclusion This method is simple, accurate, reproducible and applicable for the content determination of miconazole nitrate in Compound Miconazole Nitrate Lotion.%目的：建立测定复方咪康唑洗剂中硝酸咪康唑含量的高效液相色谱法。方法色谱柱为Eclipse XDB C18柱(250 mm ×4．6 mm，5μm )，流动相为甲醇－0．5%乙酸铵溶液(20：80)，流速为1．0 mL/min，检测波长为235 nm，柱温为30℃。结果硝酸咪康唑质量浓度在0~2．1060 g/L范围内与峰面积呈良好的线性关系( r=0．9993)，平均回收率为98．98%，RSD=1．91%( n=9)。结论该法简便快速、准确、重复性好，可用于该制剂中硝酸咪康唑的含量测定。