HPLC测定琥珀酸索利那新片中的有关物质

目的 采用HPLC法检测琥珀酸索利那新片中的有关物质.方法 采用Tianhe Kromail C18(150 mm ×4.6 mm,5μm)色谱柱,以0.05 mol·L-1磷酸氢二钾的0.1％三乙胺溶液(用20％磷酸溶液调pH4.0)乙腈为流动相,梯度洗脱,流速1.0 mL·min-1,柱温30℃,检测波长210 nm,以主成分自身对照法计算有关物质的含量.结果 主成分与有关物质能完全分离,各杂质峰的分离良好.结论 所用方法专属性强、灵敏度高、重复性好,可用于琥珀酸索利那新片中有关物质的检测.

Determination of related substances in Solifenacin succinate tablets by HPLC

OBJECTIVE To establish an HPLC method for the determination of related substances in Solifenacin succinate tablets.METHODS The analytical column was Tianhe Kromail C18 column(150 mm × 4.6 mm,5 μm).The mobile phase consisted of 0.05 mol· L-1 dipotassium hydrogen phosphate (0.1％ trimethylamine,pH4.0)-acetonitrile (75 ∶ 25) in gradient elution at a flow rate of 1.0 mL·min-1.The detection wavelength was set at 210 nm and the column temperature was 30 ℃.The content of related substance was calculated by self-control with main component.RESULTS Related substances were completely separated from the main constit uent and the impurities were separated well from each other.CONCLUSION The method is specific,sensitive and reproducible for the determination of related substances in Solifenacin succinate tablets.