HPLC法测定孟鲁司特钠片含量与有关物质

目的: 建立孟鲁司特钠片有关物质和含量测定的HPLC测定方法。 方法: 采用苯基柱(250 mm×4.6 mm,5 μm),梯度洗脱,流动相A为0.15%高氯酸钠溶液(用磷酸调节pH至4.5),流动相B为乙腈;流速1.0 mL·min^-1;检测波长为225 nm。 结果: 孟 鲁司特钠与其他杂质分离度较好,孟鲁司特钠的线性范围为4.92~73.85 μg·mL^-1(r=1.000),平均回收率为102.0%,RSD为1.2%(n=9),孟鲁司特钠检测限浓度为0.03 μg·mL^-1。 结论: 方法简便,专属性强,可作为产品质量检测方法。

Objective: To establish a method for content determination of montelukast sodium tablets and related substances. Methods: The analysis was performed on a Phenyl column(250 mm×4.6 mm,5 μm)using gradient elution of a mobile phase consisted of solvents A and B. The A solvent was 0.15%natrium perchloricum(pH 4.5 adjusted with phosphonic acid);the B solvent was acetonitrile.The flow rate was 1.0 mL·min^-1,and the detection wavelength was 225 nm. Results: Main peak and individual impurity peak were well separated.The calibration curves of Montelukast Sodium was linear in the range of 4.92-73.85 μg·mL^-1(r=1.000),and the average recoveries was 102.0%,RSD was 1.2%(n=9).The detection limit of montelukast sodium was 0.03 μg·mL^-1 . Conclusion: The method is rapid and reliable for content determination of montelukast sodium tablets and related substances.

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