论文部分内容阅读
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。
Objective To establish a method for the determination of miconazole tincture by high performance liquid chromatography. Methods A Shim-pack CLC-ODS octadecylsilane bonded silica gel column (6.0mm × 150mm, 5μm) was used. The column temperature was 30 ℃ and the mobile phase was acetonitrile-methanol-0.5% ammonium acetate solution (42.55: 42.55: 15) Phase at a flow rate of 1.0 ml / min and a detection wavelength of 230 nm. Results In the concentration range of 40 ~ 800μg / ml, the peak area showed a good linear relationship with the concentration, the correlation coefficient was 0.9997. The average recovery was 99.87% with a RSD of 0.46%. The separation of miconazole nitrate and other impurity peaks were satisfactory. Conclusion The method is simple, accurate and reliable, suitable for the quality control of miconazole tincture.