HPLC法测定愈美缓释片有关物质

Determination of Related Substances in Guaifenesin and Dextromethorphan HydrobromideExtended-Release Tablets by HPLC

目的:建立HPLC法测定愈美缓释片有关物质。方法:采用Agilent ZORBAX RX-C8(4.6 mm×250 mm,5μm)色谱柱,流动相A为0.2%三氟乙酸溶液-乙腈(体积比9∶1),流动相B为0.2%三氟乙酸溶液-乙腈-甲醇(体积比1∶2∶7),梯度洗脱,流速0.8 mL/min,柱温50℃,检测波长280 nm,进样量20μL。结果:各杂质间及主峰与相邻杂质间分离良好;各组分在浓度范围内与峰面积线性关系良好,r为0.999。结论:该方法操作简单,专属性强,准确度高,可用于愈美缓释片有关物质测定。

Objective:To establish a method for the determination of related substances in guaifenesin and dextromethorphan hydrobromide extended-release tablets by HPLC.Methods:The chromatographic column is Agilent ZORBAX RX-C8(4.6 mm×250 mm,5μm).Mobile phase A consisted of 0.2%trifluoroacetic acid solutionacetonitrile(the ratio of volume is 9∶1),mobile phase B consisted of 0.2%trifluoroacetic acid solution-acetonitrilemethanol(the ratio of volume is 1∶2∶7),gradient elution.The flow rate is 0.8 mL/min,the column temperature is 50℃,detection wavelength is 280 nm and the injection volume is 20μL.Results:The impurities and their main peaks are well separated from the adjacent impurities.Each component shows a good linear relationship with peak area,and correlation coefficient(r)are 0.999.Conclusion:The method is simple,specific and accurate,which can be used for the determination of related substances in guaifenesin and dextromethorphan hydrobromide extended-release tablets.