HPLC法测定牛黄上清丸及其药包材中DEHP的含量  

HPLC determination of di-2-ethylhexyl phthalate(DEPH) content in Niuhuang Shangqing pills and medicinal packaging materials

作　　者：李娜[1,2] 贾建忠 孙祥德 

机构地区：[1]新乡医学院药学院,新乡453003 [2]新乡医学院三全学院,新乡453003 [3]安康市食品药品检验所,安康725000

出　　处：《药物分析杂志》2013年第7期1163-1167,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立牛黄上清丸及其药包材中邻苯二甲酸二(2-乙基己基)酯(DEHP)含量的高效液相色谱测定方法。方法:采用Shim-Pack VP-ODS(150 mm×2.0 mm,5μm)色谱柱,流动相甲醇-水(95∶5),流速1.0 mL.min-1,检测波长为245 nm,柱温为30℃。结果:方法定量限0.1μg·mL-1,线性范围为0.1～100μg·mL-1,其标准曲线方程A=5.21×103C+5.20×103,r=0.9998,加标回收率为99.20%～100.3%,RSD为0.35%。结论:对32批牛黄上清丸及其药包材测定,结果表明该本方法操作简便,灵敏准确,能够满足牛黄上清丸(NSP)及其药包材(MPM)中DEHP含量的测定的需要,具有一定的应用价值。Objective： To establish a RP-HPLC method for content determination of di-2-ethylhexyl phthalate（DEPH） in Niuhuang Shangqing pills（NSP） and medicinal packaging materials（MPM）.Methods： RP-HPLC was performed on a column of Shim-Pack VP-ODS（150 mm × 2.0 mm,5 μm） with methanol-water（95∶ 5,v / v） as the mobile phase at a flow rate of 1.0 mL.min-1.The detection wavelength was 254 nm,and the column temperature was 30 ℃.Results： The detection limit was 0.1 μg.mL-1,the linear range was 0.1-100 μg.mL-1,the stand curve equation was A = 5.21 × 103C ＋ 5.20 × 103,with the correlation coefficient 0.9998.The average recoveries were 99.20%-100.3% with corresponding RSD 0.35%.Conclusion： The established method is simple,rapid,sensitive and accurate,which can be applied to the quality control of compound NSP and MPM.

关 键 词：邻苯二甲酸二(2-乙基己基)酯 增塑剂 高效液相色谱法 牛黄上清丸 牛黄上清丸药包材 

分 类 号：R917[医药卫生—药物分析学]