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目的:建立高效液相色谱法测定复方氨酚烷胺片中马来酸氯苯那敏的含量及含量均匀度。方法:采用C_(18)柱(250mm×4.6mm,5μm),以乙腈-0.3%十二烷基硫酸钠溶液-磷酸(60:40:0.02)(用三乙胺调pH至3.3)为流动相,流速为1.0ml·min~(-1),检测波长为264nm。结果:马来酸氯苯那敏在0.48～1.12μg范围内呈线性关系,r=0.999 9,平均回收率为98.0%,RSD=0.4%(n=9)。结论:该方法简便、快速,重复性好。
Objective: To establish a method for the determination of content and uniformity of chlorphenamine maleate in compound paracetamol amine tablets by high performance liquid chromatography. Methods: C 18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase of acetonitrile -0.3% sodium dodecyl sulfate solution (60:40:.02) (adjusted to pH 3.3 with triethylamine) Phase, the flow rate of 1.0ml · min ~ (-1), detection wavelength of 264nm. Results: Chlorphenamine maleate showed a linear relationship in the range of 0.48-1.12 μg with r = 0.999 9. The average recovery was 98.0% with RSD = 0.4% (n = 9). Conclusion: The method is simple, rapid and reproducible.