孟鲁司特钠咀嚼片中有关物质测定方法研究

A method for determining related substances in montelukast sodium chewable tablets

目的:采用HPLC法,建立孟鲁司特钠咀嚼片中有关物质的检测方法。方法:色谱柱:Thermo Hypersil BDS-C_(18)(100 mm×4.6 mm,3μm);柱温:40℃;流速:1.0 m L·min^(-1);流动相A:乙腈-磷酸盐缓冲液[0.02 mol·L^(-1)磷酸二氢钠水溶液,用85%磷酸调p H至(3.7±0.1)](20∶80),流动相B:乙腈-磷酸盐缓冲液(80∶20),梯度洗脱;检测波长:225 nm。结果:在选定的色谱条件下,主成分与各杂质间分离度良好,主峰纯度及物料平衡符合要求;杂质1,2,3检测限分别为0.255 8,0.132 1,0.176 0 ng,加样回收率分别为101.0%,95.0%和103.7%,耐用性结果显示,适当变化检测条件不影响杂质的检出。结论:该方法适用于孟鲁司特钠咀嚼片有关物质的检查。

Objective： To eestablish an HPLC method for determining the related substances in montelukast sodium chewable tablets. Methods： Thermo Hypersil BDS-C18（ 100 mm × 4. 6 mm,3 μm） column was used,and the column temperature was set at 40 ℃. The mobile phase was composed of acetonitrile and 0. 02 mol·L-1 phosphate buffer [p H was adjusted to（ 3. 7 ± 0. 1） by phosphoric acid]（ 20 ∶ 80 for A,and 80 ∶ 20 for B）. The flow rate was 1. 0 m L·min-1. The detection wavelength was 225 nm. Results： Impurities were completely separated from the main constituent. The main peak purity and material balance met the requirements. The LOD of impurities1,2 and 3 were 0. 255 8,0. 132 1 and 0. 176 0 ng. The average recoveries were 101. 0%,95. 0% and 103. 7%.Durability results showed that the appropriately altered detection conditions did not affect the detection of impurities. Conclusion： This method is applicable for the determination of related substance in montelukast sodium chewable tablets.