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目的:建立测定0.05%硫酸阿托品滴眼液中硫酸阿托品含量的方法。方法:色谱柱为Agilent C18柱(250 mm×4.6 mm,5μm),柱温为30℃,流动相A为磷酸盐缓冲液(0.05 mol·L-1磷酸二氢钠溶液,用稀磷酸或氢氧化钠调节p H至(3.0±0.1),流动相B为乙腈,A和B以一定的比例梯度洗脱,检测波长为210 nm,流速为1.0 ml·min-1,进样量为10μl。结果:硫酸阿托品在21.500~430.000μg·ml-1范围内线性良好(r=0.999 8),定量限为38.74 ng,平均回收率为98.95%,RSD为0.67%(n=9)。结论:建立的方法简便、灵敏、专属性好、结果准确,适用于硫酸阿托品滴眼液中硫酸阿托品含量的测定。
Objective: To establish a method for the determination of atropine sulfate in 0.05% atropine sulfate eye drops. METHODS: The column was Agilent C18 column (250 mm × 4.6 mm, 5 μm) with a column temperature of 30 ° C. The mobile phase A was phosphate buffer (0.05 mol·L -1 sodium dihydrogen phosphate solution, diluted with dilute phosphoric acid or hydrogen Sodium hydroxide adjusted p H to (3.0 ± 0.1), mobile phase B was acetonitrile, and A and B eluted with a certain gradient. The detection wavelength was 210 nm, the flow rate was 1.0 ml · min -1 and the injection volume was 10 μl. Results: The linear range was 21.500 ~ 430.000μg · ml-1 (r = 0.999 8), the limit of quantification was 38.74 ng, the average recovery was 98.95% and the RSD was 0.67% (n = 9) .Conclusion: The method is simple, sensitive, specific, and accurate, suitable for the determination of atropine sulfate in atropine sulfate eye drops.