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反相高效液相色谱法测定咪康唑氯倍他索乳膏中硝酸咪康唑和丙酸氯倍他索的含量

Determination of miconazole nitate and clobetasol propinate in compound miconazole nitrate cream by RP-HPLC

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【作者】 陈旻温梅云李晨辉陈英施若靖

【Author】 Chen Min~1,Wen Mei-yun~2,Li Chen-hui~1,Chen Ying~1,Shi Ruo-jing~3(1.Guangdong Provincial Institute for Drug Control,Guangzhou 510180;2.Antituberculosis Research Institute of Guangdong,Guangzhou 510630;3.Guangdong Pharmaceutical College,Guangzhou 510240)

【机构】 广东省药品检验所,广东省结核病防治研究所,广东省药品检验所,广东省药品检验所,广东药学院 广州510180,广州510630,广州510180,广州510180,广州510240

【摘要】 目的建立咪康唑氯倍他索乳膏中硝酸咪康唑和丙酸氯倍他索的含量测定方法。方法以十八烷基键合硅胶色谱柱,0.5%醋酸铵溶液-乙腈-甲醇(24∶38∶38,v/v/v)为流动相,检测波长为240 nm,用内标法定量,内标为邻苯二甲酸二丁酯。结果丙酸氯倍他索在0.12~1.2μg呈良好的线性关系(r=0.999 9),平均回收率为99.8%;硝酸咪康唑在4.2~48.8μg呈良好的线性关系(r=0.999 9),平均回收率为100.8%。结论该方法简便、快速、可靠,可用于该产品的质量控制。

【Abstract】 OBJECTIVE To establish a method for the determination of miconazole nitate and clobetasol propinate in compound miconazole nitrate cream by RP-HPLC.METHODS C18 column was used.The mobile phase was 0.5% ammonium acetate solutiou-aletonitrile-methanol(24∶38∶38,V/V/V),and the internal standard was Dibutyl phthalate,with a detection wavelength of 240 nm.RESULTS The standard curves of clobetasol propinate were linear over the range of 0.12~1.2 μg(r=0.999 9).The average recovery was 99.8%.The standard curve of miconazole nitate was linear over the range of 4.208~48.816 μg(r=0.999 9).The average recovery was 100.8%.CONCLUSIONS The method is simple,fast and reliable,and can be used to control the quality of this product.

  • 【文献出处】 中南药学 ,Central South Pharmacy , 编辑部邮箱 ,2005年05期
  • 【分类号】R927
  • 【被引频次】2
  • 【下载频次】53
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