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    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

    • 摘要: 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(4.6 mm×250 mm,5 μm)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1.0 mL·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0.16~0.33 mg·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。

       

      Abstract: 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, 5 μm) 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 of 0.16-0.33 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%.

       

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