高效液相色谱法测定咪康唑酊的含量

目的建立高效液相色谱法测定咪康唑酊含量的方法。方法采用Shim-pack CLC-ODS十八烷基硅烷键合硅胶柱（6.0mm×150mm,5μm）,柱温30℃,以乙腈-甲醇-0.5%醋酸铵溶液（42.55：42.55：15）为流动相,流速为1.0ml/min,检测波长为230nm。结果在40～800μg/ml浓度范围内,峰面积与浓度呈良好的线性关系,相关系数为0.9997。平均回收率为99.87%,RSD为0.46%。硝酸咪康唑与其他杂质峰的分离度均符合要求。结论本方法简便专属,准确可靠,适用于咪康唑酊的质量控制。

Determination the content of miconazole tincture by HPLC

Objective To establish a practical reversed-phase high performance liquid chromatography method to determine miconazole tincture. Methods A Shim-pack CLC-ODS C18 column（6.0 mm×150 mm,5 μm） was adopted and the column temperature was maintained at 30℃. The mobile phase was a mixture of acetonitrile-methanol-0. 5% ammonium acetate（42. 5：42. 5 ： 15） and the flow rate was 1.0 ml/min. The detection wavelength was at 230 nm. Results The calibration curves were linear within the range of 40 -800 μg/ml（ r = 0. 999 7）respectively. The average recoveries of miconasole nitrate were 99. 87% respectively, related standard deviation（ILSD） were 0. 46%. The resolution between the respective peaks of Miconazole Nitrate and the other peaks conformed to the requirements. Conclusion This method is simple, sensitive, accurate, and suitable for the quality control of miconasole tincture.