HPLC法测定盐酸苯海拉明糖浆的含量  

Determination of Diphenhydramine Hydrochloride Syrups by HPLC

作　　者：石笑弋 兰文 王伟姣 易必新 

机构地区：[1]湖南省食品药品检验研究院,长沙410001

出　　处：《中国药师》2013年第9期1369-1371,共3页China Pharmacist

摘　　要：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,5μm);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25.32~2025.60μg·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。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.

关 键 词：高效液相色谱法 盐酸苯海拉明糖浆 含量测定 

分 类 号：R927.2[医药卫生—药学]