HPLC法测定盐酸苯海拉明乳膏的含量  

Content determination of diphenhydramine hydrochloride cream by HPLC

作　　者：白林[1] 范金钊[2] 蔡乐[1] 徐风华[1] 

机构地区：[1]解放军总医院药品保障中心,北京100853 [2]安徽蚌埠医学院,安徽蚌埠233000

出　　处：《中国药物应用与监测》2014年第6期348-350,共3页Chinese Journal of Drug Application and Monitoring

基　　金：总后制剂标准提高计划重点课题:半固体制剂标准提高系列研究(13ZJZ05)

摘　　要：目的：建立测定盐酸苯海拉明乳膏含量的方法。方法：采用HPLC法,色谱柱：Platisil C18柱（250 mm×4.6 mm,5μm）;流动相：乙腈-水-三乙胺（50∶50∶0.5）;检测波长：258 nm;流速：0.8 m L·min^-1;柱温：40℃。结果：盐酸苯海拉明与其它杂质峰分离良好。盐酸苯海拉明在125.0-1 000.0μg·m L^-1范围内与峰面积呈良好的线性关系（r=1.000 0）;盐酸苯海拉明的平均回收率为98.18%,RSD=0.40%（n=9）。结论：本方法简便、准确、重复性好,可用于盐酸苯海拉明乳膏的含量测定。Objective： To establish the HPLC method for determining the content of diphenhydramine hydrochloride cream.Methods：HPLC analysis was carried out with Platisil C18column （250 mm×4.6 mm, 5μm）, the mobile phase consisted of acetonitrile-water-triethylamine （50 ： 50 ： 0.5）, the detection wavelength was 258 nm, the flow rate was 0.8 mL·min^-1 and the column temperature was 40℃.Results：The samples were separated well from impurities by this HPLC method. The calibration curve of diphenhydramine hydrochloride was linear in the range of 125.0 – 1 000.0μgmL·min^-1 （r = 1.000 0）. The average recovery and the RSD of diphenhydramine hydrochloride were 98.18%, 0.40% （n = 9）, respectively.Conclusion：This method is accurate and feasible, which can be applied as the quantitative method for the determination of diphenhydramine hydrochloride cream.

关 键 词：高效液相色谱法 盐酸苯海拉明乳膏 含量测定 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]