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对孟鲁司特钠口腔崩解片中孟鲁司特钠的百分含量进行测定, 建立该制剂的质量控制方法.采用HPLC法, 色谱柱为C18柱;以三氟乙酸-乙腈-水 (1:200:300) 为流动相;以220 nm为检测波长;柱温为室温;流速为1 m L/min;进样量为20μL.孟鲁司特钠在0. 05～0. 4 mg/m L范围内质量浓度与峰面积呈现良好的线性关系, 回归方程为y=880. 7x+11. 55, r=0. 999 9 (n=5), 平均回收率为99. 6％, RSD为2. 5％.该法操作简单, 重复性良好, 结果准确, 为孟鲁司特钠口腔崩解片的质量控制提供了基础.“,”To determine the content of montelukast sodium in the oral tablets of montelukast orally disintegrating tablets and establish the quality control method of the preparation. The HPLC method was used. The column was a phenyl column (C18 column). The detection wavelength was at 220 nm with trifluoroacetic acid-acetonitrile-water (1: 200: 300). The flow rate was 1 m L/min. Montelukast in the range of 0. 05 ～ 0. 4 mg/m L showed a good linear relationship (r = 0. 999 9). The average was 99. 6％ and RSD was 2. 5％. The HPLC method was accurate and reliable, and can be used for the quality control method of the preparation.