HPLC法测定复方咪康唑散中硝酸咪康唑含量

Determination of Miconazole Nitrate in Compound Miconazole Powders by HPLC

目的:建立高效液相色谱法测定复方咪康唑散中硝酸咪康唑的含量。方法:色谱柱:Angilent Eclipse XDB-C_(18)柱(150nn×4.6 mm,5μm),流动相:甲醇-乙腈-0.5%乙酸铵(42.5:42.5:15),检测波长:230 nm,流速:1.0 ml·min^(-1),柱温:30℃。结果:硝酸咪康唑在0.010 8～1.080 0 mg·ml^(-1)浓度范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为100.8%(RSD=1.05%,n=9)。结论:该法准确、重复性好、简便,可用于复方咪康唑散中硝酸咪康唑的含量测定。

Objective：To establish an HPLC method for the determination of miconazole nitrate in compound miconazole powders. Method：The analytical column was an Agilent Eclipse XDB-C_（18）（150 mm×4.6 mm,5μm） column,methanol-acetonirile-0.5%ammonium acetate solution（42.5：42.5：15） was used as the mobile phase with the flow rate of 1.0 ml ？ min^（-1）,the detection wavelength was 230 nm and the column temperature was 30℃.Result：The calibration curve was linear within the concentration range of 0.010 8- 1.080 0 mg ？ ml^（-1）（r =0.999 9）,and the average recovery was 100.8%（RSD = 1.05%,n = 9）.Conclusion：The HPLC method is simple,accurate and reproducible,and can be used in the content determination of compound miconazole powders.