高效液相色谱法测定苯海拉明乳膏中盐酸苯海拉明的含量  

Quantitative Determination of Diphenhydramine Hydrochloride in Diphenhydramine Creams Using HPLC Method

作　　者：孙芳[1] 景霞[1] 湛雯[1] 徐进[1] 

机构地区：[1]南京医科大学附属南京儿童医院,江苏南京210008

出　　处：《儿科药学杂志》2016年第9期48-50,共3页Journal of Pediatric Pharmacy

基　　金：南京医科大学科技发展基金重点项目;编号2012NJMU068

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-C_（18）（4.6 mm×150 mm,5μm）;流动相为甲醇-0.03 mol/L磷酸二氢钠溶液（50∶50,含0.1%三乙胺,p H 3.0）;检测波长258 nm;柱温为室温（25℃）;流速0.9 m L/min;进样量20μL。结果：盐酸苯海拉明浓度在0.200 8~2.007 5 mg/m L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。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 eluted by methanol-0.03 mol / L sodium dihydrogen phosphate（ 50︰50,0.1% triethylamine included,adjusting p H to 3.0） with a flow rate of 0.9 m L / 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 / m L（ r =0.999 9）. RSD for precision,stability and reproducibility tests were respectively 1.51%,1.92% and 2.65%. The average recovery was100.03%（ 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.

关 键 词：盐酸苯海拉明 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学]