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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。
Objective: To establish a HPLC method for the determination of related substances in timolol maleate eye drops. Methods: The chromatographic column was Venusil MP-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of phosphate buffer (0.05 mol·L -1 sodium dihydrogen phosphate, Amine, pH adjusted to 3.0 with phosphoric acid) -acetonitrile (85:15); detection wavelength at 295 nm; flow rate of 1.0 ml.min-1 and column temperature of 25 ° C. Results: The separation of timolol maleate and its degradation product was good with the minimum detection limit of 2.0 ng. Conclusion: The established method is reliable, sensitive and accurate. It can be used for the related substances examination of timolol maleate eye drops.