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高效液相色谱法测定自制苯海拉明乳膏中羟苯乙酯的含量 被引量:3

Determination of ethyl hydroxybenzoate in diphenhydramine cream by HPLC
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摘要 目的 建立测定医院自制制剂苯海拉明乳膏中羟苯乙酯的含量测定方法。方法 采用高效液相色谱法(HPLC)。色谱柱:AgilentEclipsePlusC18(4.6mm×250mm,5μm)色谱柱;流动相:甲醇-0.03mol·L^-1磷酸二氢钾溶液(含0.1%三乙胺,用50%磷酸调pH3.0±0.03)=60∶40;检测波长:258nm;柱温:25℃;流速:0.9mL·min^-1;进样体积:20μL。结果 羟苯乙酯测定质量浓度在0.02-0.10g·L^-1范围内与其相应峰面积积分值呈良好线性关系(r=0.9995);精密度、稳定性、重复性试验相对标准偏差(RSD)分别为1.6%、1.9%、2.0%;平均绝对回收率为92.7%,RSD为4.3%(n=9);平均相对回收率为102.5%,RSD为3.6%(n=9)。结论 该方法专属性、重复性、准确性较好,可用于苯海拉明乳膏中羟苯乙酯的含量测定。 Objective To establish a method of quantitative determination of ethyl hydroxybenzoate in diphenhydramine cream.Meth-ods The HPLC method was adopted with the Agilent Eclipse Plus-C18 column(4.6 mm ×250 mm,5 μm)at room temperature(25℃)and methanol-0.03 mol·L^-1 phosphoric acid solution(pH adjusted to 3.0 ±0.03)(60∶40)as the mobile phase at the flow rate of 0.9 mL·min^-1 .The detection wavelength for ethyl hydroxybenzoate was 258 nm,and the injection volume was 20 μL.Results The good linear relationship for ethyl hydroxybenzoate was in the range of 0.02 ~0.10 g·L^-1 (r =0.999 5).RSDs of ethyl hydroxybenzo-ate for precision,stability and reproducibility tests were 1.6 %,1.9% and 2.0 %,respectively.The average absolute recovery of ethyl hydroxybenzoate was 92.7%(RSD =4.3 %,n =9),while the average relative recovery was 102.5 %(RSD =3.6 %,n =9).Con-clusions This established method was specific,accurate and reproducible for the quantitative determination of ethyl hydroxybenzoate in diphenhydramine cream.
出处 《安徽医药》 CAS 2016年第9期1655-1658,共4页 Anhui Medical and Pharmaceutical Journal
关键词 防腐剂 药物 色谱法 高压液相 苯海拉明 药物调剂 羟苯乙酯/分析 Preservatives,pharmaceutical Chromatography,high pressure liquid Diphenhydramine Drug compounding Ethyl hydroxy-benzoate /analysis
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