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目的:建立UFLC法测定复方氨酚烷胺片中对乙酰氨基酚和咖啡因的含量。方法:shim-pack XR-ODSH C_(18)柱(75mm×2.0mm,2.2μm),以0.058mol·L~(-1)的磷酸二氢铵溶液-甲醇-三乙胺(80:30:0.05 pH3.4)为流动相,检测波长为215nm、柱温为40℃、流速为0.7ml·min~(-1)。结果:对乙酰氨基酚和咖啡因分别在0.24~6.0mg·ml~(-1)(r=0.9996)和0.016~0.40mg·ml~(-1)(r=0.9991)范围内呈现良好的线性关系;回收率分别为99.86%和99.65%,RSD分别为0.48%和0.88%(n=9)。结论:方法简便、迅速、重复性好,可作为该制剂质量控制的方法。
Objective: To establish the UFLC method for the determination of acetaminophen and caffeine in compound paracetamol tablets. METHODS: The shim-pack XR-ODSH C 18 column (75mm × 2.0mm, 2.2μm) was prepared with 0.058mol·L -1 ammonium dihydrogen phosphate solution-methanol- 0.05 pH3.4) was used as the mobile phase. The detection wavelength was 215nm, the column temperature was 40 ℃ and the flow rate was 0.7ml · min ~ (-1). RESULTS: Paracetamol and caffeine showed good linearity in the range of 0.24-6.0 mg · ml -1 (r = 0.9996) and 0.016-0.40 mg · ml -1 (r = 0.9991) The recovery rates were 99.86% and 99.65%, respectively, with RSDs of 0.48% and 0.88%, respectively (n = 9). Conclusion: The method is simple, rapid, reproducible and can be used as a quality control method of the preparation.