HPLC法测定奋乃静及奋乃静片有关物质方法的建立

目的：建立HPLC法测定奋乃静及奋乃静片有关物质。方法：采用Kromasil C18（4.6mm×250mm,5μm）为色谱柱,流动相：A为甲醇,B为0.03mol·L^-1醋酸铵溶液,梯度洗脱;流速为1.0mL·min^-1,检测波长254nm。结果：奋乃静与其相关杂质分离度良好,在0.1～50μg·mL^-1浓度范围内与峰面积呈良好的线性关系（r=0.99998,n=7）,奋乃静最低检出限为2ng。结论：本方法专属性好,灵敏度高,结果准确,可用于奋乃静及奋乃静片的有关物质检查。

Determination of related substances in perphenazine and perphenazine tablets by HPLC

Objective：To establish an HPLC method for the analysis of related substances in perphenazine and perphenazine tablets.Methods：A Kromasil C18 column（4.6 mm×250 mm,5 μm） was used for separation with the mobile phase consisting of methanol（A） and 0.03 mol·L^-1 ammonium acetate（B） in gradient elution model.The flow rate was 1.0 mL·min^-1,and the detection wavelength was 254 nm.Results：The good resolution between perphenazine and related substances was achieved.A linearity between peak area and perphenazine concentration was obtained in the range of 0.1–50 μg·mL^-1（r=0.999 98,n=7）,and the limit of detection of perphenazine was 2 ng.Conclusion：The method is specifi c,sensitive,accurate and can be used for quality control of related substances in perphenazine and perphenazine tablets.