RP-HPLC梯度洗脱法测定吡嘧司特钾滴眼液的有关物质

Determination of Pemirolast Potassium Eye Drops Related Substances by RP-HPLC with Gradient Elution

目的建立RP-HPLC梯度洗脱法测定吡嘧司特钾滴眼液的有关物质。方法采用WATERS Sunfire C 18分析柱(250 mm×4.6 mm,5μm),流动相A为甲醇-三氟乙酸(1→1000)(1∶4),流动相B为甲醇-三氟乙酸(1→1000)(3∶2),检测波长为260 nm,柱温为40℃。结果在选定的色谱条件下,吡嘧司特钾与有关物质完全分离;滴眼液中基质无干扰。结论本法具有灵敏高、分离效果佳、检查结果准确等优势,可用于吡嘧司特钾滴眼液的有关物质检查。

OBJECTIVE To establish a RP-HPLC method for the determination of pemirolast potassium eye drops related substances with gradient elution.METHODS Using WATERS Sunfire C 18 column(250 mm×4.6 mm,5um),the mobile phase A was methanol-trifluoroacetic acid(1→1000)(1∶4),phase B was methanol-trifluoroacetic acid(1→1000)(3∶2),the detection wavelength was 260 nm,and the column temperature was 40℃.RESULTS Under the selected chromatographic conditions,it could separate related substances from main drug and formulation excipients without interference.CONCLUSION The method has several advantages,such as sensitivity,better separation effect and accurate examination results,and can be used in quality control of pemirolast potassium eye drops preparations.