1673-159X

CN 51-1686/N

枸橼酸坦度螺酮胶囊有关物质研究

Study on Related Substances of Tandospirone Citrate Capsules

  • 摘要: 目的: 建立枸橼酸坦度螺酮胶囊有关物质检查方法。方法: 采用高效液相色谱法, 以UltimateTM XB-C18 (250 mm×4.6 mm, 5μm) 为色谱柱; 流动相: 0.01 mol/L磷酸二氢钾溶液体积∶乙腈体积(60∶40);检测波长: 215 nm。结果: 有效的分离了枸橼酸坦度螺酮胶囊中的有关物质, 杂质A不得过0.3%, 杂质B不得过0.4%, 各杂质峰面积的和不大于对照溶液主峰面积的1.0。结论: 此方法简便、快速, 可用于枸橼酸坦度螺酮胶囊的质量控制。

     

    Abstract: HPLC was employed to determine the related compounds in tandospirone citrate capsules.The determination was performed on ultimateTM XB-C18 (250mm×4.6mm, 5μm) column, and the mobile phase was composed of methanol-solution of 0.01mol/L MKP-acetonitrile (60:40) and detection wavelength of 243nm.The related substances in tandospirone citrate capsules were separated effectively.The peak area of A foreign material was no more than 0.3% and the peak area of B foreign material was no more than 0.4%, and the total peak area of all foreign materials was no more than 1.0% of the main peak area of contrast solution.The method is simple and rapid, suitable for the quality control of tandospirone citrate capsules.

     

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