HPLC测定硝酸咪康唑尿素乳膏中硝酸咪康唑的含量

Determination the Content of Miconazole Nitrate in Miconazole Nitrate and Urea Cream by HPLC

目的建立高效液相色谱法测定硝酸咪康唑尿素乳膏中硝酸咪康唑的含量。方法Agilent TC—C18（4．6mm×150mm，5μm）色谱柱；流动相：0．5％醋酸铵溶液．乙腈和甲醇（1：1）混合液（16．5：83．5）；流速：1．0mL·min^-1；检测波长：230nm。结果硝酸咪康唑在0．1928—1．9284mg·mL^-1的浓度内线性关系良好（r=0．9991），平均回收率为98．21％，RSD=1．41％（n=9）。结论此法操作简便、结果准确、精密度好，可用于硝酸咪康唑尿素乳膏的质量控制。

OBJECTIVE To establish an HPLC method for deteimination the content of mieonazole nitrate in Mieonazole Nitrate and Urea Cream. METHODS The Agilent TC-C18 column（4. 6 mm × 150 mm,5 μm）was used with the 0. 5% ammonium acetate solution-aeetonitril-methanol （16. 5：41.75： 41.75） as mobile phase. The flow rate was 1.0 mL · min^-1, and the detection wavelength was 230 nm. RESULTS The linear rang of miconazole nitrate was 0. 192 8 - 1. 9284 mg · mL^-1 , r = 0. 999 1, and the average recovery was 98. 21% with RSD1.41%. CONCLUSION The method is simple and accurate,it can be used for quality control of Miconazole Nitrate and Urea Cream.