HPLC法测定马来酸噻吗洛尔滴眼液中有关物质

目的:建立HPLC法测定马来酸噻吗洛尔滴眼液中的有关物质。方法:色谱柱为Venusil MP-C18色谱柱(250 mm×4.6 mm,5μm),流动相:磷酸酸盐缓冲液(0.05 mol.L-1磷酸二氢钠,每1 000 ml加0.5 ml三乙胺,以磷酸调节pH至3.0)-乙腈(85∶15);检测波长295 nm;流速1.0 ml.min-1,柱温为25℃。结果:马来酸噻吗洛尔与其降解产物分离良好,其最低检出限2.0 ng。结论:所建立的方法稳定性可靠、灵敏、结果准确,可用于马来酸噻吗洛尔滴眼液有关物质检查。

Determination of Related Substances in Timolol Maleate Eye Drops by HPLC

Objective： To establish an HPLC method for the determination of the related substances in timolol maleate eye drops. Method： A Venusil MP-C18 column（250 mm ×4.6 mm,5μm） was used with phosphate buffer solution（0.05 mol · L-1 NaH2PO4, adding 0.5 ml triethylamine per 1 000 ml, adjusting pH to 3.0 with phosphoric acid）-acetonitrile （85：15 ） as the mobile phase, the flow rate was 1.0 ml min-1 , the detection wavelength was 210 nm, and the column temperature was 25℃ Result： The LOD of the impurities was 2.0 ng. Conclusion： The method is reliable, stability and sensitivity, and can be used in the quality control of timolol maleate eye drops.