HPLC法测定孟鲁司特钠咀嚼片的含量及有关物质

Content Determination and Related Substances of Montelukast Sodium Chewable Tablets by HPLC

目的:建立孟鲁司特钠咀嚼片含量测定及有关物质检查的方法。方法:采用高效液相色谱法。色谱柱为VenusilXBPC18(L),流动相为乙腈-0.025mol/L乙酸铵溶液(含0.02%十二烷基硫酸钠,pH值8.0)(68:32,V/V),流速为1.0ml/min,柱温为25℃,检测波长为270nm。结果:在选定的色谱条件下,主成分能与各杂质之间良好分离。孟鲁司特钠检测质量浓度线性范围为0.05～0.3mg/m(lr=0.9999),平均回收率为98.9%,RSD=0.4%(n=9),定量限为3.7ng。结论:建立的测定方法灵敏度高、专属性强,可用于孟鲁司特钠咀嚼片的质量控制。

OBJECTIVE： To establish a method for the content determination of Montelukast sodium chewable tablets and the related substances. METHODS： HPLC method was adopted. The determination was performed on a Venusil XBP C18 （L） column with mobile phase consisted of acetonitrile-0.025 mol/L ammonium acetate solution containing 0.02% sodium laurylsulfate （pH ad- justed to 8.0, 68 ： 32, V/V） at the flow rate of 1.0 ml/min. The column temperature was set at 25 %. The detection wavelength was set at 270 nm. RESULTS： Related substances were completely separated from the main constituent. The linear rang of montelukast sodium was 0.05-0.3 mg/ml （r=0.999 9） with an average recovery of 98.9% （RSD=0.4%, n=9）. The limit of quantitation for montelukast sodium was 3.7 ng. CONCLUSIONS： The method is simple and specific, which can be used for the quality control of Montelukast sodium chewable tablets.