HPLC法测定盐酸苯海拉明乳膏的含量

目的建立以高效液相色谱法测定盐酸苯海拉明乳膏含量的方法。方法色谱柱:Kromasil C18(250mm×4.6mm,5μm);流动相:乙腈-10mL.L-1三乙胺溶液(32∶68);检测波长:258nm;流速:1.0mL.min-1;柱温:室温。结果盐酸苯海拉明在0.099 41～0.994 1mg.mL-1范围内质量浓度与峰面积线性关系良好(r=0.999 8),平均回收率为99.1%,RSD为1.4%。结论该方法精密度好,专属性强,重复性好,回收率高,可准确控制制剂的含量。

Content determination of Diphenhydramine Hydrochloride Creams by HPLC

Objective To establish an HPLC method for the content determination of Diphenhydramine Hydrochloride Creams.Methods The column was Kromasil C18(250 mm×4.6 mm,5 μm) operated at room temperature;the mobile phase was acetonitrile-10 mL·L-1triethylamine(32∶68) with flow rate of 1.0 mL·min-1,and the detection wavelength was at 258 nm.Results A good linear relationship was obtained between the peak areas and the concentrations of diphenhydramine hydrochloride in the range from 0.099 41 to 0.994 1 mg·mL-1(r=0.999 8).The average recovery was 99.1%(RSD=1.4%).Conclusion This method is accurate,reliable,reproducible and can be used for the quality control of Diphenhydramine Hydrochloride Creams.