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目的:建立用 RP-HPLC 法测定氨咖敏片中氨基比林、咖啡因和马来酸氯苯那敏含量的方法。方法:用 Kromasil C_(18)柱(250 mm×4.6 mm,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1.0ml·min~(-1),检测波长215 nm。结果:氨基比林、咖啡因和马来酸氯苯那敏分别在30.2～90.5μg·ml~(-1)(r=0.999 9),2.8～8.4μg·ml~(-1)(r=0.999 6)和10.1～30.2μg·ml~(-1)(r=0.999 9)范围内呈线性关系,平均回收率分别为99.4%,RSD=0.3%(n=9),99.6%,RSD=0.5%(n=9)和99.3%,RSD 0.4%。结论:本法简单、快速和准确,适用于氨咖敏片质量控制。
Objective: To establish a method for the determination of aminopyrine, caffeine and chlorphenamine maleate in aminocapril tablets by RP-HPLC. Methods: The mobile phase was eluted with Kromasil C 18 column (250 mm × 4.6 mm, 5 μm) with acetonitrile-0.3% sodium dodecyl sulfate solution (60:40:.02) (adjusted to pH 3.3 with triethylamine) As mobile phase, the flow rate was 1.0ml · min ~ (-1) and the detection wavelength was 215 nm. Results: Aminopyrine, caffeine and chlorpheniramine maleate were significantly higher in the range of 30.2-90.5μg · ml -1 (r = 0.999 9), 2.8- 8.4μg · ml -1 (r = The average recoveries were 99.4%, RSD = 0.3% (n = 9), 99.6%, RSD = 0.999 6 and 10.1 ~ 30.2μg · ml -1 (r = 0.999 9) 0.5% (n = 9) and 99.3%, RSD 0.4%. Conclusion: This method is simple, rapid and accurate, suitable for the quality control of ammonia caffeine tablets.