HPLC法测定体外透皮接收液中盐酸麻黄碱

Determination of ephedrine hydrochloride in transdermal solution by HPLC

目的建立体外透皮接收液中盐酸麻黄碱的HPLC测定方法。方法采用Shim-pack VP-ODS色谱柱(250mm×4.6mm,5μm,SHIMADZU),流动相:甲醇-0.02mol/L KH2PO4水溶液(2∶3);柱温:35℃;流速:1.0mL·min-1;检测波长:257nm。用Franz扩散装置对0.2%盐酸麻黄碱溶液进行体外透皮实验,分别在不同时间点取样测定透皮接收液盐酸麻黄碱浓度,计算累积透皮量。结果盐酸麻黄碱的标准曲线方程为C=0.0021A-2.458(r=0.9997),线性范围1.0～100mg·L-1,平均回收率为102.4%。结论本方法稳定,重现性好,结果准确,是考察盐酸麻黄碱体外透皮性能的较理想的方法。

Objective To establish an HPLC method for the determination of ephedrine hydrochloride in transdermal solution. Methods The HPLC method was used with Shim-pack VP-ODS C18 （250 mm×4.6 mm, 5 μm, SHIMADZU）. The mobile phase consisted of methanol and 0.02 mol/L potassium dihydrogen phosphate solution （2：3）. The temperature of column was at 35 ℃. The flow rate was 1.0 mg·L^-1. The detection wavelength was at 257 nm. Prepare 0.2 % ephedrine hydrochloride solution and use Franz diffusion cell to investigate its cumulative release amount. Results The regression equation of ephedrine hydrochloride was linear in the range of 1.0-100 mg·L^-1 （C= 0.0021 A - 2.458,r = 0.9997）. The average recovery was 102.4%. Conclusions The method was stable and accurate. It is a better method to determine ephedrine hydrochloride in transdermal solution.