高效液相色谱法测定硝酸咪康唑栓的含量

Quantitative Determination of Miconazole Nitrate in Miconazole Nitrate Suppository with HPLC

目的建立测定硝酸咪康唑栓含量的高效液相色谱(HPLC)法。方法色谱柱为C18柱(150mm×4.6mm,5μm),流动相为甲醇-乙腈-0.5%乙酸铵(42.5∶42.5∶5),检测波长为230nm。结果硝酸咪康唑质量浓度在0.02～0.2mg/mL范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为101.3%,RSD为1.80%(n=9)。结论HPLC法准确、重现性好、简单,适用于硝酸咪康唑栓的含量测定。

Objective To establish a method for the determination of miconazole nitrate in Miconazole Nitrate Suppository with HPLC. Methods The HPLC consisted of Phenomenex C18 column（150 mm×4.6 mm, 5 μm）, methanol-acetonitfile-0.5% ammonium acetate （45.2：42. 5：15） mixture as the mobile phase, the detection wavelength at 230 nm. The flow rate was 1.0 mL/min. Results The linear range was good in the range of 0.02-0. 2 mg/mL, the average recovery rate was 101.3% and RSD was 1.80% （n=9）. Conclusion The HPLC method is simple and accurate. It fits the content determination of Miconazole Nitrate Suppository.