HPLC法测定硫酸阿托品滴眼液中硫酸阿托品的含量

Determination of Atropine Sulfate in Atropin Sulfate Eye Drops by HPLC

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（250mm×4．6mm，5μm），柱温为30℃，流动相A为磷酸盐缓冲液（0．05mol·L^-1磷酸二氢钠溶液，用稀磷酸或氢氧化钠调节pH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210nm，流速为1．0ml·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=0．9998），定量限为38．74ng，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 to determine the content of atropine sulfate in atropin sulfate eye drops, Methods： The column was Agilent C 18 （250mm×4.6mm,5μm） with the temperature of 30 ℃. The mobile phase consisted of phosphate buffer [ 0.05 mol · L^-1 sodium dihydrogen phosphate solution with pH （3.0 ± 0.1 ） adiusted by phosphoric acid or sodium hydroxide ] and acetonitrile with gradient elution. The flow rate was 1.0 ml · min^- 1 and the injection volume was 10 μl. The detection wavelength was set at 210 nm. Results ： The linear range of atropine sulfate was 21. 500-430.000 μg· ml ^-1 （ r = 0.999 8 ）. The limit of quantification was 38.74 ng. The average recovery was 98.95 % （ RSD = 0.67 %, n = 9）. Conclusion ： The method is simple, sensitive, selective and accurate, which can be used in the determination of atropine sulfate in atropin sulfate eye drops.