HPLC外标法测定孟鲁司特钠的有关物质

目的：建立一种有效测定孟鲁司特钠中有关物质的高效液相色谱法。方法：采用苯基柱（250 mm×4.6 mm,5μm）;流动相A为0.15%三氟乙酸水溶液;流动相B为0.15%三氟乙酸乙腈溶液,梯度洗脱,柱温为35℃;检测波长为238 nm;体积流量为1.5 ml/min;进样量为20μl。结果：孟鲁司特《欧洲药典》中的各杂质都具有良好的线性关系（r〉0.999 5）。结论：本方法简便准确、重现性好、精密度高,可有效地检测孟鲁司特钠中有关物质。

Determination of related substances in montelukast sodium by HPLC

Objective： To establish an HPLC method for the determination of related substances in montelukast sodium. Methods： For separation,a phenyl column（ 250 mm × 4. 6 mm,5 μm） was used as stationary phase with gradient elution using water（ A） and acetonitrile（ B） as mobile phase. Both solutions A and B contained 0.15% of trifluoroacetic acid. The flow rate of the mobile phase was 1. 5 ml /min,and the detection wavelength at 238 nm. The analysis was performed at 35 ℃,and the injection size was 20 μl. Results： The linear coeffcients for impurities of montelukast sodium defined in European Pharmacopoeia were all more than 0. 999 5. Conclusion： This method is simple,accurate,precise,and suitable for the determination of related substances in montelukast sodium.