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HPLC法测定盐酸苯海拉明乳膏的含量
引用本文:白林,;范金钊,;蔡乐,;徐风华.HPLC法测定盐酸苯海拉明乳膏的含量[J].中国药物应用与监测,2014(6):348-350.
作者姓名:白林  ;范金钊  ;蔡乐  ;徐风华
作者单位:[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
基金项目: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。

关 键 词:高效液相色谱法  盐酸苯海拉明乳膏  含量测定

Content determination of diphenhydramine hydrochloride cream by HPLC
Institution:BAI Lin, FAN Jin-zhao, CAI Le, XU Feng-hua(1. Department of Pharmaceutical Care, PLA General Hospital, Beijing 100853, China; 2. Bengbu Medical College, Bengbu 233000, China)
Abstract: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.
Keywords:HPLC  Diphenhydramine hydrochloride cream  Content determination
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