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目的:建立同时测定硫酸阿托品滴眼液中硫酸阿托品及羟苯乙酯含量的方法。方法:采用Shim-pack CLC-C_8色谱柱,流动相为甲醇-无水乙醇-水-三乙胺(47:12:41:0.1),用冰醋酸调节pH至4.7,流速为1.0ml·min~(-1),检测波长为256nm。结果:硫酸阿托品和羟苯乙酯的线性范围分别为25～250μg·ml~(-1)(r=0.9999),1～10μg·ml~(-1)(r=0.9996);平均回收率分别为99.82%、100.07%,日内、日间RSD均小于2.0%。结论:本方法简便、快速、准确,适用于硫酸阿托品滴眼液的质量控制。
Objective: To establish a method for the simultaneous determination of atropine sulfate and hydroxypropiophenol sulfate in atropine sulfate eye drops. Methods: Shim-pack CLC-C_8 column was used. The mobile phase was methanol-absolute ethanol-water-triethylamine (47: 12: 41: 0.1). The pH was adjusted to 4.7 with glacial acetic acid and the flow rate was 1.0 ml · min ~ (-1), the detection wavelength is 256nm. Results: The linear range of atropine sulfate and ethylparaben was 25 ~ 250μg · ml ~ (-1) (r = 0.9999) and 1 ~ 10μg · ml ~ (-1) (r = 0.9996) Which was 99.82% and 100.07% respectively. The intra-day and inter-day RSDs were less than 2.0%. Conclusion: The method is simple, rapid and accurate and is suitable for the quality control of atropine sulfate eye drops.