HPLC法测定复方苯海拉明乳膏中盐酸苯海拉明的含量

Diphenhydramine hydrochloride asaay in compound diphenhydramine cream by HPLC

目的建立HPLC法测定复方苯海拉明乳膏中盐酸苯海拉明的含量。方法色谱柱为ACE5C_(18)S/NA66766柱(150 mm×4.6 mm,5μm);流动相为甲醇-水-三乙胺(70:30:0.67,用磷酸调pH为6.5);检测波长设定230 nm;流速设定1.0 ml/min;乳膏经过提取净化后进样20μl在室温下分析。结果盐酸苯海拉明在39.52~197.6μg/ml范围内线性关系良好(r=0.9997),平均回收率为100.5%(RSD=1.25%,n=9),重复性结果显示RSD为0.78%(n=6),所测得盐酸苯海拉明乳膏含量结果为标示量的101.3%、99.83%、99.62%。结论本方法准确、灵敏、专属性强、重现性好,对复方苯海拉明乳膏质量控制标准的提高具有参考意义。

Objective To establish the HPLC method of assay for diphenhydramine hydrochloride in compound diphenhydramine cream.Method HPLC analysis was carried on ACE5C_(18)S/N-A66766 column(150 mm×4.6 mm,5μm)with the mobile phase of methanol-water-triethylamine(70:30:0.67,adjusting pH to 6.50 with phosphoric acid)at room temperature.The detection wavelength was set at 230 nm and the flow rate was 1.0 ml/min.The analyte was extracted from the cream and 20μl of sample was injected.Results The calibration curve of diphenhydramine hydrochloride was linear in the range of 39.52-197.6μg/ml(r=0.9997).The average recovery of diphenhydramine hydrochloride was 100.5%(RSD=1.25%,n=9).The repeatability of the method was expressed using RSD with 0.78%(n=6).The results of assay were 101.3%,99.83%and 99.62%.Conclusion The method is accurate,sensitive,selective and repeatable,which can be applied for improving the quality standard of compound diphenhydramine cream.