摘要
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。
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.
出处
《中国药物应用与监测》
CAS
2010年第2期88-90,102,共4页
Chinese Journal of Drug Application and Monitoring
基金
国家药典委员会2010年版<中国药典>工作