枸橼酸坦度螺酮胶囊有关物质研究

Study on Related Substances of Tandospirone Citrate Capsules

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。

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.