醋酸曲安奈德益康唑乳膏中硝酸益康唑有关物质的测定  

Determination of Econazole Nitrate related substances in Triamcinolone Acetonide Acetate and Econazole Nitrate Cream

作　　者：肖梦杰 肖学成[1] 薛大权[1] 崔开宇[1] 涂皓[1] 吴莹[1] 朱雅莲 XIAO Meng-jie XIAO Xue-cheng XUE Da-quan CUI Kai-yu TU Hao WU Ying ZHU Ya-lian(College of Pharmacy,Hubei University of Traditional Chinese Medicine,Wuhan 430065,Chin)

机构地区：[1]湖北中医药大学药学院,湖北武汉430065

出　　处：《中国当代医药》2017年第6期11-14,18,共5页China Modern Medicine

摘　　要：目的建立HPLC法测定醋酸曲安奈德益康唑乳膏中硝酸益康唑有关物质的方法。方法采用ZORBAX Eclipse XDB-C18(4.6 mm×100.0 mm,3.5μm)为色谱柱,以甲醇-0.077%醋酸铵溶液(20∶80)为流动相A,以甲醇-乙腈(40∶60)为流动相B,进行梯度洗脱,检测波长为225 nm;流速1.0 ml/min;柱温为35℃。结果硝酸益康唑与各杂质分离度良好,硝酸益康唑在0.2~100.0μg/ml的浓度范围内峰面积与浓度之间呈良好的线性关系,回归方程为y=15.6295x+4.5920(r=0.999 97)。结论此方法测定醋酸曲安奈德益康唑乳膏中硝酸益康唑的有关物质简单可行。Objective To establish a HPLC method for the determination ofrelated substances of Econazole Nitrate in Triamcinolone Acetonide Acetate and Econazole Nitrate Cream.Methods The ZORBAX Eclipse XDB-CIs （4.6 mm×100.0 mm,3.5 μm） column was adopted.The mobile phase consisted of a mixture of Methanol-0.077% solution of Ammonium Acetate （20：80） as mobile phase A,a mixture of Methanol-Acetonitrile （40：60） as mobile phase B,which was used as gradient elution.The detection wavelength was 225 nm.The flow rate was 1.0 ml/min,and the column temperature was 35℃.Results Econazole Nitrate was well separated from impurity.The calibration curves was linear in range of 0.2-100.0μg/ml for Econazole Nitrate,the regression equation was y=15.6295x＋4.5920 （r=0.999 97）.Conclusion This method is simple and feasible to determine the related substances of Econazole Nitrate in Triamcinolone Acetonide Acetate and Econazole Nitrate Cream.

关 键 词：醋酸曲安奈德益康唑乳膏 硝酸益康唑 有关物质 HPLC 

分 类 号：R917[医药卫生—药物分析学]