高效液相梯度洗脱法测定依巴斯汀片的有关物质

目的用高效液相色谱法测定依巴斯汀片的有关物质。方法采用氰基色谱柱Discovery cyano(150mm×4.6mm,5μm);检测波长为210nm;采用A相(磷酸盐缓冲液,pH5.0)-B相(乙腈650mL与A相350mL混合)为流动相进行梯度洗脱;流速为0.9mL.min-1;柱温为40℃;进样量为10μL,程序进样。结果本方法实现了将制剂中引入的有关物质与主成分之间的基线分离。结论本色谱条件适合依巴斯汀片有关物质的测定。

Determination of related subtance in Ebastine Tablets by HPLC gradientelution

OBJECTIVE To establish an HPLC method for determination of related substances in Ebastine Tablets.METHODS Discovery cyano column(150mm×4.6mm,5μm) was used,the mobile phase was the mixture of A(phosphate buffer,pH5.0)-B [acetonitrile-A(650∶ 350)].The elution was performed at the flow rate of 0.9mL·min-1.UV detective wavelength was 210nm,the column temperature was 40℃,and sample volume was 10μL.RESULTS The better resolution was performed between related substances and Ebastine.CONCLUSION This method was suitable for determination of related substances in Ebastine Tablets.