孟鲁司特钠口腔崩解片的百分含量测定

Determination of montelukast sodium orally disintegrating tablets by HPLC

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(C 18 column).The detection wavelength was at 220 nm with trifluoroacetic acid-acetonitrile-water(1:200:300).The flow rate was 1 mL/min.Montelukast in the range of 0.05~0.4 mg/mL 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.