HPLC法测定孟鲁司特钠起始物料1-(巯甲基)环丙基乙酸中的有关物质

HPLC determination of related substances in montelukast sodium starting material 2-[1-(mercaptomethyl)-cyclopropyl]acetic acid

目的建立高效液相色谱法测定孟鲁司特钠起始物料1-(巯甲基)环丙基乙酸中的有关物质。方法使用C18色谱柱,流动相A为0.1%磷酸溶液,流动相B为乙腈,线性梯度洗脱,检测波长222 nm,流速1 mL·min^-1。结果1-(巯甲基)环丙基乙酸与其他杂质峰均分离完全,1-(巯甲基)环丙基乙酸及其2个杂质均在相应范围内与峰面积线性关系良好,2个杂质的平均回收率均大于96%。结论本法操作简便,灵敏度高,可用于1-(巯甲基)环丙基乙酸中有关物质的测定及产品质量控制。

Objective To determine the related substances in montelukast sodium starting material 2-[1-(mercaptomethyl)-cyclopropyl] acetic acid by HPLC. Methods A syncronis C18 column was used, with the mobile phase A of 0.1% phosphoric acid, and mobile phase B of acetonitrile for linear gradient elution, the detection wavelength was 222 nm, and the flow rate was 1 mL·min-1. Results Under the above chromatographic conditions, 2-[1-(mercaptomethyl)-cyclopropyl] acetic acid and other impurity peaks were completely separated. The calibration curves of 2-[1-(mercaptomethyl)-cyclopropyl] acetic acid and two related substances were linear with their correponding ranges, and the recoveries of two related substances were higher than 96.0%. Conclusion This method is simple, accurate, and suitable for the quality control of 2-[1-(mercaptomethyl)-cyclopropyl] acetic acid.