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 C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.5％KH2PO4(35:65),流速为1 mL/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=0.99986,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 C18 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 mL/min and detection wavelength was 217 nm. Results The linear range of atropine sulfate was 40. 0-163. 0 g/L ( r=0. 99986, 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.
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