反相高效液相色谱法测定盐酸奥洛他定片的含量

Determination of Olopatadine Hydrochloride Tablets by RP-HPLC

目的采用反相高效液相色谱法测定盐酸奥洛他定片的含量。方法色谱柱为Zorbax SB-C18柱(250mm×4.5mm,5μm),流动相为0.02mol/L磷酸二氢钠溶液(含0.2%辛烷基磺酸钠,用浓磷酸调pH至3.0)-乙腈(65∶35),流速1.5mL/min,检测波长210nm,柱温为室温,进样量10μL。结果盐酸奥洛他定质量浓度在0.05～0.35g/L范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为99.56%,RSD=0.72%(n=6)。结论所用方法专属性好,操作简便、快速,结果准确可靠,重现性好,可作为盐酸奥洛他定片的含量测定方法。

Objective To establish an RP-HPLC method for the determination of Olopatadine Hydrochloride Tablets.Methods The Zorbax SB-C18 column （250 mm×4.5 mm,5 μm） was used as analytical column.The mobile phase consisted of 0.02 mol/L NaH2PO4 containing 0.2%sodium 1-octane sulfonate （adjusting pH to 3.0 with H3PO4）-acetonitrile （65 ∶35） with the flow rate of 1.5 mL/min,the detection wavelength was 210 nm and the column temperature was at room temperature.The injection volume was 10 μL.Results The linear range for the content of olopatadine hydrochloride was 0.05-0.35 g/L（r=0.999 9）,the average recovery rate was 99.56%,RSD=0.72%（n=6）. Conclusion The method is simple,rapid,accurate,which is suitable for the content determination of Olopatadine Hydrochloride Tablets.