| 湛雯,徐进,孙芳,等.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[J].安徽医药,2016,20(9):1655-1657. |
| 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 |
| Determination of ethyl hydroxybenzoate in diphenhydramine cream by HPLC |
| 投稿时间：2016-04-14 |
| DOI： |
| 中文关键词: 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 |
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| 中文摘要: |
| 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:Agilent Eclipse Plus-C18(4.6 mm× 250 mm,5 μm)色谱柱；流动相:甲醇-0.03 mol·L-1磷酸二氢钾溶液(含0.1%三乙胺,用50%磷酸调pH 3.0±0.03)=60∶40；检测波长:258 nm；柱温:25℃；流速:0.9 mL·min-1；进样体积:20 μL。结果 羟苯乙酯测定质量浓度在0.02~0.10 g·L-1范围内与其相应峰面积积分值呈良好线性关系(r=0.999 5)；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。 |
| 英文摘要: |
| Objective To establish a method of quantitative determination of ethyl hydroxybenzoate in diphenhydramine cream.Methods 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 hydroxybenzoate 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).Conclusions This established method was specific,accurate and reproducible for the quantitative determination of ethyl hydroxybenzoate in diphenhydramine cream. |
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