HPLC法测定盐酸苯海拉明糖浆的含量

目的：建立以高效液相色谱法测定盐酸苯海拉明糖浆含量的方法.方法：色谱柱：Kromasil CN（250 mm×4.6 mm,5 μm ）;流动相：1%三乙胺溶液（用冰醋酸调节pH至6.5）-乙腈 （50：50）;检测波长：258 nm;流速：1.0 ml·min-1;柱温：30℃.结果：盐酸苯海拉明在25.32～2025.60 μg·ml-1范围内线性关系良好（r=0.999 9）,平均回收率为99.39%,RSD为0.47%（n=9）.结论：该方法准确可靠,专属性强,重复性好,可用于控制制剂的质量.

Determination of Diphenhydramine Hydrochloride Syrups by HPLC

Objective ： To establish an HPLC method for the determination of diphenhydramine hydrochloride syrups. Method： The column was Kromasil CN （ 250 mm x 4.6 mm, 5 μm） , the mobile phase was 1% triethylamine （ adjusting pH to 6.5 with glacial acetic acid）-acetonitrile （50： 50） with a flow rate of 1.0 ml · min-1, the detection wavelength was at 258 nm and the column temperature was 30 . Result： A good linear relationship was obtained between the peak area and the concentration of diphenhydramine hydro chloride within the range of 25.32-2025.60 p·g · ml-1 （ r = 0.999 9 ）. The average recovery was 99.39% （ RSD = 0.47%, n = 9 ）. Conclusion： The method is accurate, reliable, specific and reproducible, and can be used in the quality control of diphenhydramine hydrochloride syrups.