HPLC法同时测定复方酮康唑凝胶剂中酮康唑和丙酸氯倍他索的含量
投稿时间:2006-01-25    点此下载全文
引用本文:张倩,宋洪涛,陈雅娉,康鲁平.HPLC法同时测定复方酮康唑凝胶剂中酮康唑和丙酸氯倍他索的含量[J].药学实践杂志,2006,(6):336~339
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作者单位
张倩 福建医科大学药学院,福建福州350004 
宋洪涛 南京军区福州总医院药剂科,福建福州350025 
陈雅娉 福建医科大学药学院,福建福州350004 
康鲁平 南京军区福州总医院药剂科,福建福州350025 
中文摘要:目的:建立复方酮康唑凝胶剂中酮康唑和丙酸氯倍他索的含量测定方法。方法:采用高效液相色谱法,色谱柱为Hypersil ODS2 C18柱,甲醇-0.2%三乙胺(醋酸调pH至6.9,V:V=75:25)为流动相,流速1.0 mL/min.检测波长239nm。结果:酮康唑在10.08~201.16μg/mL浓度范围内呈良好的线性关系,r=0.9999;丙酸氯倍他索在0.251~5.02μg/mL浓度范围内呈良好的线性关系,r=0.9998。酮康唑的平均回收率为99.59%,RSD为0.77%;丙酸氯倍他索的平均回收率为100.76%,RSD为1.18%。结论:本方法分离度好,简便,准确,适用于复方酮康唑凝胶剂中2组分的同时测定,可作为产品的质量控制方法。
中文关键词:高效液相色谱法  复方酮康唑凝胶剂  酮康唑  丙酸氯倍他索
 
Simultaneous determination of ketoconazole and clobetasol propionate in compound ketoconazole gel by HPLC
Abstract:Objective:To establish a method for simultaneous determination of ketoconazole and clobetasol propionate in compound ketoconazole gel.Methods:HPLC method was developed.Chromatographic conditions included Hypersil ODS2 C18 column and the mo- bile phase was methanol-0.2% triethylamine(adjust with acetic acid to a pH of 6.9,V:V=75:25).The flow rate was 1.0 mL/ min and the UV detection wavelength was at 239 nm.Results:Ketoconazole had a good linearity(r=0.9999) in the range of 10.08~201.16μg/mL,its average recovery was 99.59%(RSD=0.77%).Clobetasol propionate had a good linearity(r=0.9998) in the range of 0.251~5.02μg/mL,its average recovery was 100.76%(RSD=1.18%).Conclusion:The method was simple, sensitive and accurate for simultaneous determination of the two constituents in compound ketoconazole gel.
keywords:HPLC  compound ketoconazole gel  ketoconazole  clobetasol propionate
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