OBJECTIVE:To establish a method for simultaneous determination of ephedrine hydrochloride,nitrofural and di-phenhydramine hydrochloride in Compound diphenhydramine nasal drop. METHODS:RP-HPLC method was adopted. The determi-nation was performed on Inertsil ODS-3 C18 column with mobile phase consisted of 0.05 mol/L potassium dihydrogen phosphate buf-fer(pH 7.0)-acetonitrile(gradient elution)with flow rate of 1.0 mL/min. The detection wavelength was set at 256 nm,and the col-umn temperature was 35 ℃. The sample size was 20 μL. RESULTS:The concentrations of phedrine hydrochloride,nitrofural and diphenhydramine hydrochloride ranged 122.1-366.3 μg/mL(r=0.9999),5.2-15.5 μg/mL(r=0.9998)and 31.5-94.5 μg/mL(r=0.9994),respectively. The limits of quantitation were 2.442,0.010,2.520 μg/mL,and the limits of detection were 0.810,0.003, 0.830 μg/mL,respectively. RSDs of precision,stability and reproducibility tests were lower than 1.0%. The recoveries of them were 99.2%-101.7%(RSD=0.9%,n=9),96.4%-102.0%%(RSD=1.7%,n=9),100.2%-101.9%(RSD=0.4%,n=9),respec-tively. CONCLUSIONS:The method is simple,accurate and reproducible,and can be used for simultaneous determination of ephedrine hydrochloride,nitrofural and diphenhydramine hydrochloride in Compound diphenhydramine nasal drop.%目的:建立同时测定复方苯海拉明滴鼻液中盐酸麻黄碱、呋喃西林、盐酸苯海拉明含量的方法.方法:采用反向高效液相色谱法.色谱柱为Inertsil ODS-3 C18,流动相为0.05 mol/L磷酸二氢钾缓冲液(pH 7.0)-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为256 nm,柱温35℃,进样量为20μL.结果:盐酸麻黄碱、呋喃西林、盐酸苯海拉明检测质量浓度线性范围分别为122.1~366.3μg/mL(r=0.9999)、5.2~15.5μg/mL(r=0.9998)、31.5~94.5μg/mL(r=0.9994);定量限分别为2.442、0.010、2.520μg/mL,检测限分别为0.810、0.003、0.830μg/mL;精密度、稳定性、重复性试验的RSD<1.0%;加样回收率分别为99.2%~101.7%(RSD=0.9%,n=9),96.4%~102.0%(RSD=1.7%,n=9),100.2%~101.9%(RSD=0.4%,n=9).结论:该方法操作简便、结果准确、重复性好,适用于复方苯海拉明滴鼻液中盐酸麻黄碱、呋喃西林、盐酸苯海拉明含量的同时测定.
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