反相离子对高效液相色谱法测定复方苯海拉明滴鼻液中盐酸苯海拉明和盐酸麻黄碱的含量

Content Determination of Diphenhydramine Hydrochloride and Ephedrine Hydrochloride in Compound Diphenhydramine Nasal Drops by Ion-pair RP-HPLC

目的:建立同时测定复方苯海拉明滴鼻液中盐酸苯海拉明和盐酸麻黄碱含量的方法。方法:采用反相离子对高效液相色谱法。色谱柱为AgilentZORBAXEclipseXDB-C18;流动相为0.02mol·L-1十二烷基硫酸钠水溶液(用85%磷酸溶液调节pH至2其.8他5)成-甲分醇分-三离乙良胺好(;522组∶4分8∶进0.样5)量,流线速性为范1围.0分mL别.m为in0-.51;0柱02温～为5.03002℃0(;r紫=外0.检99测98波,n长=为6)2、546.0n0m5。8～结4果0.:0盐58酸0苯μg(海r=拉0明.9、9盐94酸,n麻=黄6)碱;与平均回收率分别为100.2%(RSD=1.2%,n=9)、99.5%(RSD=1.1%,n=9)。结论:该方法专属性强,结果准确、可靠,可用于测定复方苯海拉明滴鼻液中盐酸苯海拉明和盐酸麻黄碱的含量。

OBJECTIVE： To establish the method for the content determination of diphenhydramine hydrochloride and ephedrine hydrochloride in Compound diphenhydramine nasal drops. METHODS： Ion-pair RP-HPLC method was adopted. Agilent ZORBAX Eclipse XDB-C18 column was used with 0.02 mol·L^-1 sodium laurylsulfate solution （pH adjusted to 2.85 with 85% phosphate acid solution）-methanol-triethanolamine （52：48：0.5） at the flow rate of 1.0mL·min^-1. The UV detection wavelength was set at 256 nm. The column temperature was 30 ℃. RESULTS： Diphenhydramine hydrochloride and ephedrine hydrochloride could be well isolated from other substances. The calibration curve was linear in the range of 0.500 2 to 5.002 0 μg for diphenhydramine hydrochloride （r=0.999 8, n=6）. The calibration curve was linear in the range of 4.005 8 to 40.058 0 μg for ephedrine hydrochloride （r=0.999 4, n=6）. The average recovery of diphenhydramine hydrochloride was 100.2% （RSD=1.2%, n=9）, and that of ephedrine hydrochloride was 99.5% （RSD=1.1%, n=9）. CONCLUSION： The method is specific, accurate and reliable for the content determination of diphenhydramine hydrochloride and ephedrine hydrochloride in Compound diphenhydramine nasal drops.