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目的:建立以高效液相色谱法测定盐酸苯海拉明糖浆含量的方法。方法:色谱柱:Kromasil CN(250 mm×4.6 mm,5μm);流动相:1%三乙胺溶液(用冰醋酸调节pH至6.5)-乙腈(50∶50);检测波长:258 nm;流速:1.0 ml·min~(-1);柱温:30℃。结果:盐酸苯海拉明在25.32~2025.60μg·ml~(-1)范围内线性关系良好(r=0.999 9),平均回收率为99.39%,RSD为0.47%(n=9)。结论:该方法准确可靠,专属性强,重复性好,可用于控制制剂的质量。
Objective: To establish a method for the determination of diphenhydramine hydrochloride syrup by high performance liquid chromatography. Methods: The chromatographic column was Kromasil CN (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 1% triethylamine (adjusted to pH 6.5 with glacial acetic acid) -acetonitrile (50:50) : 1.0 ml · min ~ (-1); column temperature: 30 ℃. RESULTS: Diphenhydramine hydrochloride had a good linear relationship (r = 0.999 9) in the range of 25.32-2025.60μg · ml -1 with an average recovery of 99.39% and a RSD of 0.47% (n = 9). Conclusion: The method is accurate, reliable, specific, reproducible and can be used to control the quality of the preparation.