应用高效液相色谱法测定缬沙坦氨氯地平片有关物质

摘要

Objective To establish a HPLC method for determining the related substances of valsartan and amlodipine tablets. Methods With octadecylsilane chemically bonded silica as the filler,the mixture of triethylamine(adjusting pH to 2.8 with phos-phoric acid)-methanol-acetonitrile was acted as the mobile phase by the gradient elution.The flow rate:1 .0 mL/min.The tempera-ture:40 ℃.The detection wavelength:238 nm.The injection volume:10μL.Results With octadecylsilane chemically bonded sili-ca as the filler,the mixture of triethylamine(adjusting pH to 2.8 with phosphoric acid)-methanol-acetonitrile was acted as the mo-bile phase by the gradient elution.The flow rate:1.0 mL/min.The temperature:40 ℃.The detection wavelength:238 nm.The injection volume:10μL.Conclusion This method is simple and accurate with good system suitability and can be used as the test method for the related substances of valsartan and amlodipine tablets.%目的：建立一种高效液相色谱（HPLC）法测定缬沙坦氨氯地平片有关物质。方法用十八烷基硅烷键合硅胶为填充剂；以三乙胺溶液（用磷酸调 pH值至2．8）-甲醇-乙腈作为流动相，梯度洗脱，流速1．0 mL/min，柱温40℃，检测波长238 nm，进样量10μL。结果其降解产物与主峰在该色谱条件下能够有效分离。结论该方法简便、准确，系统适用性好，可作为缬沙坦氨氯地平片有关物质的检验方法。