HPLC法测定盐酸奥洛他定滴眼液的含量

Determination of Olopatadine Hydrochloride in Olopatadine Hydrochloride Eye Drops by HPLC

目的建立HPLC测定盐酸奥洛他定滴眼液含量的方法。方法以十八烷基键合硅胶为填充剂,流动相0.05 mol/L磷酸二氢钾-乙腈-三乙胺(760:240:2),用磷酸调pH至4.5,检测波长254 nm,流速1.0 mL/min。结果盐酸奥洛他定在0.05～0.15 mg/mL范围内呈良好的线性关系(r=0.999 7),平均回收率100.2%(n=9),RSD=0.99%。结论HPLC方法简便灵敏准确,重复性好,可用于盐酸奥洛他定的质量控制。

Objective To determine the content of olopatadine hydrochloride in olopatadine hydrochloride eye drops.Methods A C18 column was used with the mobile phase of 0.05 mol/L potassium dihydrogen phosphate-acetonitrile-triethylamine（760：240：2）.The phosphoric acid was used to adjust pH to 4.5.The detection wavelength was 254nm.The flow rate was 1.0 mL/min.Results The calibration curve was linear in the range of 0.05～0.15 mg/ mL for olopatadine hydrochloride（r = 0.999 7）.The average recovery was 100.2 %（n = 9,RSD = 0.99 %） for olopatadine hydrochloride.Conclusion This method is simple,sensitive and accurate with a good repeatability for the quality control of olopatadine hydrochloride eye drops.