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目的建立高效液相色谱法测定孟鲁司特钠的有关物质。方法色谱柱为Ultimate XB-C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-体积分数0.1%磷酸溶液(体积比62∶38),流速为2.0 m L·min-1,检测波长为238 nm。结果孟鲁司特钠及有关物质C质量浓度在0.30~4.2 mg·L-1内,有关物质D/E、F、G质量浓度在0.22~3.1 mg·L-1内,有关物质B质量浓度在0.45~6.3 mg·L-1内与峰面积呈良好的线性关系(r>0.999)。有关物质B、C、D/E、F及G的平均回收率分别为99.9%、101.4%、100.3%、101.6%和100.2%,RSD分别为1.1%、1.3%、1.4%、0.7%和1.0%(n=9)。结论本方法简便、专属、准确,可用于孟鲁司特钠的有关物质检查。
Objective To establish a HPLC method for the determination of montelukast sodium related substances. Methods The column was an Ultimate XB-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution with a volumetric ratio of 62:38 and a flow rate of 2.0 m L · min- 238 nm. Results The concentrations of montelukast sodium and related substances were 0.30-4.2 mg · L-1, the concentrations of D / E, F and G were 0.22-3.1 mg · L-1, In 0.45 ~ 6.3 mg · L-1 and the peak area showed a good linear relationship (r> 0.999). The average recoveries for the substances B, C, D / E, F and G were 99.9%, 101.4%, 100.3%, 101.6% and 100.2%, respectively, with RSDs of 1.1%, 1.3%, 1.4%, 0.7% and 1.0% % (n = 9). Conclusion This method is simple, specific, accurate, and can be used for the related substance examination of montelukast sodium.