反相高效液相色谱法同时测定复方特比奈芬乳膏中二组分的含量  

Simultaneous determination of two ingredients in compound terbinafine cream by reversed-phase HPLC

作　　者：郭珉[1] 李萨菁 林翠华[1] 张志勤[1] 韩国柱[3] 

机构地区：[1]大连市皮肤病医院药剂科,大连116021 [2]大连市药品检验所,大连116021 [3]大连医科大学药理教研室,大连116044

出　　处：《中国新药杂志》2009年第22期2167-2169,2171,共4页Chinese Journal of New Drugs

摘　　要：目的：建立一种反相高效液相色谱测定法,同时测定复方特比奈芬乳膏中二组分的含量。方法：采用Kromasil-C18柱（150 mm×4.6 mm,5μm）;流动相为甲醇-醋酸铵缓冲液（1.15g醋酸铵＋水300 mL＋冰醋酸1 mL用三乙胺调pH至5～6）（70∶30）。采用变流速洗脱方式：1～8 min流速为1.0 mL.min-1,此后按线性梯度增加流速,至10 min时为1.5 mL.min-1,并维持该流速至25 min。检测波长为254 nm。结果：盐酸特比奈芬与曲安奈德分离良好（R〉2.0）且不受基质成分的干扰;上述2种成分分别在100～1 600μg.mL-1和10～160μg.mL-1范围内具有良好的线性关系（r=0.999 9和r=0.999 9）,回收率分别为98.7%-100%（盐酸特比奈芬）,98.2%～99.8%（曲安奈德）。结论：该方法专属性强,精密度高,可同时测定制剂中盐酸特比奈芬和曲安奈德二组分的含量,操作简便,可作为该制剂质量控制标准。Objective：To develop an HPLC method for simultaneous determination of two ingredients in compound terbinafine cream.Methods：The chromatographic separation was achieved on a Kromasil-C18 column（150mm×4.6mm,5μm）using a mobile phase consisting of MeOH-NH4Ac buffer [（1.15g ammonium acetate ＋ 300mL water ＋1mL glacial HAc adjusted to pH 5～6 with（C2H5）3N）]（70∶30） running at a gradient flow rate：1.0mL·min-1at 1～8min,and then changed to 1.5mL·min-1 at 25min.The detection wavelength was set at 254nm.Results： ：Terbinafine was well separated from triamcinolone （ R 〉 2.0） ; there was no interference from matrix. The calibration curve showed good linearity over the range of 100 - 1600μg· mL-1 for terbinafine （r = 0. 999 9） and 10 ～ 160μg·mL-1 for triamcinolone （r =0. 999 9）. The recovery was 98.7% - 100% for terbinafine and 98.2% -99.8% for triamcinolone. Conclusion：The present method has high specificity and precision, and is able to simultaneously determine contents of two ingredients in the cream with procedure being simple and, therefore, can be used for the quality control of the cream preparation.

关 键 词：高效液相色谱 特比奈芬 曲安奈德 乳膏 

分 类 号：R927.2[医药卫生—药学] R978.5