HPLC法测定艾曲波帕片含量和有关物质

Determination of the Content and Related Substances in Eltrombopag Tablets by HPLC

目的:建立艾曲波帕片含量测定及有关物质测定的方法。方法:采用HPLC法,色谱柱为辛烷基硅烷键合硅胶C8柱(150 mm×4.6 mm,5μm),以0.01 mol·L^-1磷酸二氢钾缓冲液(磷酸调节pH至3.0)为流动相A,乙腈为流动相B,甲醇为流动相C,梯度洗脱,流速为1.0 ml·min^-1,检测波长为230 nm,柱温为40℃,进样量为10μl。结果:在选定的色谱条件下,主成分与各杂质峰分离度良好。艾曲波帕浓度在0.1968~0.5905 mg·ml^-1范围内与峰面积有良好的线性关系(r=1.0000),平均回收率为99.5%(RSD=0.5%,n=9)。结论:该方法简便、准确、灵敏,可用于艾曲波帕片的含量和有关物质测定。

Objective:To establish a method for the determination of the content and related substances in eltrombopag tablets.Methods:An HPLC method with gradient elution was used on an octylsilane bonded silica gel C8 column(150 mm×4.6 mm,5μm).The mobile phase A was 0.01 mol·L^-1 potassium dihydrogen phosphate buffer(adjusting pH to 3.0 with phosphoric acid),the mobile phase B was acetonitrile,and the mobile phase C was methanol.The flow rate was 1.0 ml·min^-1,the detection wavelength was 230 nm,the column temperature was 40℃,and the injection volume was 10μl.Results:The related substances could be completely separated from the main component under the selected chromatographic conditions.A good linear relationship was found between the peak areas and the concentrations of eltrombopag within the range of 0.1968-0.5905 mg·ml^-1(r=1.0000)with the average recovery of 99.5%(RSD=0.5%,n=9).Conclusion:The method is simple,accurate and sensitive,and can be used for the determination of the content and related substances in eltrombopag tablets.