高效液相色谱法测定盐酸右哌甲酯缓释微丸的有关物质及含量

摘要

Objective To establish an HPLC method for determination of related substances of dexmethylphenidate hydrochloride and their content .Methods The HPLC method was used on an Agilent ZORBAX SB-C18 column with a mo-bile phase of methanol-0.2%triethyl citrate in 25 mmol/L potassium dihydrogen phosphate ( pH was adjusted to 3.5 with phosphoric acid) (35∶65) at a flow rate of 1.0 ml/min.The detection wavelength was 209 nm and column temperature was 40℃.Results Under the selected chromatographic condition , dexmethylphenidate hydrochloride was completely separated from impurity.The limit of detection was 81.12 ng/ml.The calibration curve was linear in the range of 2-30 μg/ml ( r=0.9995).The average recovery of the method was 100.83%, and the stability of the working solution was acceptable in 12 h(RSD=0.10%).Conclusion This method is simple,specific,accurate and suitable for analyzing the related substances and their content in dexmethylphenidate hydrochloride .%目的：应用高效液相色谱技术建立盐酸右哌甲酯缓释微丸有关物质检查和含量测定的方法。方法采用Agilent ZORBAX SB-C18色谱柱（250 mm ×4．6 mm，5μm）；磷酸二氢钾溶液[25 mmol／L，三乙胺0．2％（v／v），磷酸调至pH 3．5]－甲醇（65∶35）为流动相，检测波长209 nm，流速1．0 ml／min，柱温40℃。结果在选定的色谱条件下，盐酸右哌甲酯与相关杂质分离良好，制剂辅料不干扰盐酸右哌甲酯的测定；检测限为81．12 ng／ml（S／N＝3），在质量浓度2～30μg／ml范围内，盐酸右哌甲酯与峰面积线性关系良好，相关系数r为0．9995；平均回收率为100．83％，溶液在12 h内保持稳定（ RSD为0．10％）。结论该方法简便、准确、专属性强，可用于盐酸右哌甲酯缓释微丸有关物质及其含量的测定。