高效液相色谱法测定含对乙酰氨基酚、氢溴酸右美沙芬和琥珀酸多西拉敏的软胶囊有关物质

Determination of Related Substances in Soft Capsules Containing Acetaminophen,Dextromethorphan Hydrobromide and Doxylamine Succinate by HPLC Method

目的建立同时检测含对乙酰氨基酚、氢溴酸右美沙芬和琥珀酸多西拉敏的软胶囊有关物质的方法。方法采用高效液相色谱法(HPLC),色谱柱:Phenomenex Luna C18(250×4.6 mm,5μm);流动相:流动相A为多库酯钠和乙酸铵的水溶液,流动相B为乙腈-冰醋酸(2∶1),梯度洗脱;检测波长:280 nm;柱温:30℃。结果各主成分和各已知杂质在相应的浓度范围内与峰面积成良好的线性关系,r=1.00;平均回收率在91%~114%范围内,相对标准偏差(RSD)均小于10%。定量限(相对于供试品浓度水平)均低于0.05%。结论该法简便高效,灵敏度高,准确度、精密度好,可用于含对乙酰氨基酚、氢溴酸右美沙芬和琥珀酸多西拉敏的软胶囊有关物质的质量控制。

Objective To establish a method for the determination of related substances in soft capsules containing acetaminophen,dextromethorphan hydrobromide and doxylamine succinate at the same time.Methods An HPLC was performed on a column:of Phenomenex Luna C18,(250×4.6 mm,5μm)with the mobile phase mobile phase A:aqueous solution of docusate sodium salt and ammonium acetate,mobile phase B:acetonitrile-glacial acetic acid(2:1)at detection wavelength of 280 nm and column temperature of 30°C by gradient elution.Results For all main components and specified impurities,the calibration curve was linear(r=1.00)over corresponding concentration range;the average recovery rate is in the range of 91%-114%,and all the RSD are less than 10%.All the limits of quantification relative to test sample solution concentration were lower than 0.05%.Conclusion The method is simple and efficient,has high sensitivity,good accuracy and precision,and can be used for the quality control of related substances in soft capsules containing paracetamol,dextromethorphan hydrobromide and doxylamine succinate.