高效液相色谱法测定硫酸阿托品滴眼液的含量

Content Determination of Atropine Sulfate Eye-Drops by HPLC

目的建立测定硫酸阿托品滴眼液含量的高效液相色谱法。方法色谱柱采用瑞士Spherigel C_(18)柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.5%KH_2PO_4(35∶65),流速为1 m L/min,检测波长为217 nm。结果硫酸阿托品质量浓度在40.0~163.0 g/L范围内与峰面积线性关系良好(r=0.999 86,n=7);平均回收率为101.33%,RSD=1.74%(n=9);日内精密度RSD分别为0.52%,0.33%,0.30%(n=5);日间精密度RSD分别为1.67%,1.20%,0.89%(n=5)。结论该法简便、敏捷、准确,可用于硫酸阿托品的质量控制。

Objective To establish an HPLC method for the content determination of Atropine Sulfate Eye-Drops. Methods The Switzerland Spherigel C（18） column（ 150 mm × 4. 6 mm, 5 μm） was adopted with carbinol-0. 5% KH2PO4（ 35 ∶ 65） as mobile phase, the flow rate was 1 m L/min and detection wavelength was 217 nm. Results The linear range of atropine sulfate was 40. 0-163. 0 g/L（ r =0. 999 86, n = 7）, the average recovery rate was 101. 33%, RSD = 1. 74%（ n = 9）. The inter-day precision（ RSD） were 0. 52%,0. 33%,0. 30%（ n = 5）,the intra-day precision（ RSD） were 1. 67%,1. 20%,0. 89%（ n = 5）. Conclusion This method is simple,rapid and accurate,which can be used for quality control of atropine sulfate.