高效液相色谱法测定依巴斯汀片中相关杂质组分的含量

Determination of Related Impurities in Ebastine Tablets by HPLC

采用高效液相色谱法(HPLC)测定依巴斯汀片中相关杂质的含量。利用苯基键合硅胶xtimate phenylhexyl色谱柱(4.6mm×250mm,5μm)分离,以磷酸盐缓冲溶液-乙腈(60+40)混合溶液为流动相A,磷酸盐缓冲溶液-乙腈(70+30)混合溶液为流动相B,流量为1.0mL·min^-1。结果表明:4种杂质的质量浓度在一定范围内与其对应的峰面积之间呈线性关系,检出限(3S/N)在0.16~0.33mg·L^-1之间。以依巴斯汀片样品为基质,按照标准加入法进行回收试验,回收率在96.0%~104%之间,测定值的相对标准偏差(n=6)在0.83%~4.2%之间。

Determination of related impurities in ebastine tablets by high performance liquid chromatography.Phenyl bonded silica gel xtimate phenylhexyl chromatographic column(4.6 mm×250 mm,5μm)was used for separation,with phosphate buffer solution-acetonitrile(60+40)mixed solution was used as the mobile phase A,and the phosphate buffer solution-acetonitrile(70+30)mixed solution was used as the mobile phase B at the flow rate of 1.0 mL·min^-1.As shown by the results,linear relationships between values of peak area and mass concentration of the 4 impurities were found in the definite ranges,with detection limits(3S/N)in the range of0.16-0.33 mg·L^-1.Test for recovery by standard addition method was made on the base of ebastine tablet sample,giving results in the range of 96.0%-104%,and RSDs(n=6)ranged from 0.83%to 4.2%.