HPLC法测定硝酸布康唑阴道乳膏中硝酸布康唑的含量

Determination of the content of butoconazole nitrate in butoconazole nitrate vaginal cream by HPLC

目的建立测定硝酸布康唑阴道乳膏中硝酸布康唑含量的HPLC法。方法色谱柱为Luna SEX(250 mm×4.6 mm,5μm)阳离子交换柱,流动相为0.016 6 mol·L^(-1)醋酸钾溶液(用冰醋酸调pH值至4.3)-甲醇(27:73,V/V),检测波长225 nm,流速1.1 mL·min^(-1)。结果硝酸布康唑为5.164～41.312 mg·L^(-1)时线性关系良好(r=0.999 8,n=5),平均回收率为99.71% (RSD=0.6%)。结论本法操作简便、灵敏度高、重现性好。

AIM To establish a HPLC method for determination of the content of butoconazole nitrate in butoconazole nitrate vaginal cream. METHODS lama SCX（250 min×4.6 mm,5 μm） column was used;mobile phase was 0.016 6 mol· L^-1 KAc （adjust pH 4.3 with glacial acetic acid） - CH3OH （27：73, V/V） ;detection wavelength was 225 nm and flow rate was 1.1 mL·min^-1 RESULTS There was good linearity in the range of 5. 164 to 41. 312 mg· L^-1 （r =0.999 8,n =5）.The average recovery was 99.71%（RSD= 0.6%）. CONCLUSION This method is simple,sensitive and good in repeatability.