HPLC法同时测定复方酮康唑凝胶中酮康唑、硝酸咪康唑的含量  

Simultaneous Determination of Ketoconazole and Miconazole Mitrate in Compound Toconazole Gels by HPLC

作　　者：黄文涛[1] 程璐[1] 

机构地区：[1]武汉市中西医结合医院药学部,武汉430022

出　　处：《中国药师》2014年第2期310-311,共2页China Pharmacist

基　　金：武汉市卫生局课题(编号:WX13D01)

摘　　要：目的：建立同时测定复方酮康唑凝胶中酮康唑、硝酸咪康唑含量的方法。方法：采用HPLC法，色谱柱为HypersilBDSC18（416mm×200mm，5μm）；以0.5%醋酸铵溶液-0.2%三乙胺的甲醇溶液（20∶80）为流动相；流速为1.0ml·min-1；检测波长为230nm，柱温：30℃，进样量20μl。结果：酮康唑在5.1～510.0mg·L-1浓度范围内有良好的线性关系，r=0.9999。平均回收率为100.3%（RSD=0.38%，n=6）。硝酸咪康唑在5.0～500.0mg·L-1浓度范围内有良好的线性关系，r=0.9999，平均回收率=99.9%（RSD=0.79%，n=6）。结论：该方法能简便、快速、准确、灵敏地同时测定酮康唑、硝酸咪康唑的含量，可以用于复方酮康唑凝胶的质量控制。Objective： To establish a method for the determination of ketoconazole and miconazole nitrate in compound ketoconazole gels. Methods： An HPLC method was developed. A Hypersil BDS C18 column（416 mm×200 mm，5 μm） was used, the mobile phases consisted of 0.5% ammonium acetate solution methanol（containing 0.2% triethanolamine） （20∶80）, the flow rate was 1.0 ml·min-1, the detection wavelength was set at 230nm, the column temperature was 30℃ and the injection volume was 20 μl. Results：There was a good linear correlation within the range of 5.1-510.0 mg·L-1 for ketoconazole （r=0.999 9） and 50.0-500.0 mg·L-1 for miconazole nitrate （r=0.999 9）, the average recovery for ketoconazole and miconazole nitrate was 100.3%（RSD=0.38%, n=6） and 99.9%（RSD=0.79%, n=6）, respectively. Conclusion：The method is simple, rapid, accurate and sensitive, and can provide a method for controlling the quality of compound ketoconazole gels.

关 键 词：高效液相色谱 复方酮康唑凝胶 酮康唑 硝酸咪康唑 含量测定 

分 类 号：R927.2[医药卫生—药学]