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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 establish a HPLC method for the determination of related substances in montelukast sodium chewable tablets. Methods: The column was Thermo Hypersil BDS-C 18 (100 mm × 4.6 mm, 3 μm). The column temperature was 40 ℃ and the flow rate was 1.0 m L · min -1. The mobile phase A was acetonitrile-phosphate Buffer [0.02 mol·L -1 sodium dihydrogenphosphate aqueous solution, adjusted to pH 3.7 ± 0.1 with 85% phosphoric acid (20:80), mobile phase B: acetonitrile-phosphate buffer : 20), gradient elution; detection wavelength: 225 nm. Results: Under the selected chromatographic conditions, the separation of the main component and each impurity was good, the purity of the main peak and the material balance met the requirements. The detection limits of impurities 1, 2 and 3 were 0.255 8, 0.132 and 0.176 0 ng, respectively The recoveries were 101.0%, 95.0% and 103.7%, respectively. Durability results showed that the appropriate detection conditions did not affect the detection of impurities. Conclusion: This method is suitable for montelukast sodium chewable tablets related substances.