| 摘要: |
| 目的:建立苯海拉明乳膏中盐酸苯海拉明的含量测定方法。方法:采用高效液相色谱(HPLC)法。色谱柱为Agilent Eclipse Plus-C18(4.6 mm±150 mm,5 μm);流动相为甲醇鄄0.03 mol/L磷酸二氢钠溶液(50:50,含0.1%三乙胺,pH 3.0);检测波长258 nm;柱温为室温(25℃);流速0.9 mL/min;进样量20 μL。结果:盐酸苯海拉明浓度在0.200 8~2. 007 5 mg/mL浓度范围内与峰面积积分值呈良好线性关系(r=0.999 9);精密度、稳定性、重复性实验RSD分别为1.51%、1.92%、2.65%;平均回收率为100.03%,RSD为1.00%(n=9)。结论:该方法专属性强,重复性好,准确性高,可用于苯海拉明乳膏中盐酸苯海拉明的含量测定。 |
| 关键词: 盐酸苯海拉明 高效液相色谱法 含量测定 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2016.09.017 |
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| 基金项目:南京医科大学科技发展基金重点项目,编号2012NJMU068。 |
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| Quantitative Determination of Diphenhydramine Hydrochloride in Diphenhydramine Creams Using HPLC Method |
| Sun Fang, Jing Xia, Zhan Wen, Xu Jin |
| (Nanjing Children's Hospital Affiliated to Nanjing Medical University, Jiangsu Nanjing 210008, China) |
| Abstract: |
| Objective: To establish a method of quantitative determination of diphenhydramine hydrochloride in diphenhydramine creams. Methods: HPLC analytic method was used. The Agilent Eclipse Plus-C18 column was used at room temperature (25 ℃) and luted by methanol-0.03 mol/L sodium dihydrogen phosphate (50:50, 0.1% triethylamine included, adjusting pH to 3.0) with a flow rate of 0.9 mL/min. The detection wavelength was 258 nm and the injection volume was 20 μL. Results: A good linear relationship was obtained between the peak areas and the concentrations of diphenhydramine hydrochloride ranging from 0.200 8 to 2.007 5 mg/ mL (r=0.999 9). RSD for precision, stability and reproducibility tests were respectively 1.51%, 1.92% and 2.65%. The average recovery was 100.03% (RSD=1.00%, n=9). Conclusion: This established method which was specific, accurate and reproducible could be used for quantitative determination of diphenhydramine hydrochloride in diphenhydramine creams. |
| Key words: diphenhydramine hydrochloride HPLC quantitative determination |
