苯磺酸氨氯地平片的有关物质检查方法研究

Examination of Related Substances in Amlodipine Bensylate Tables by RP-HPLC with Ultraviolet Detection

目的建立检查苯磺酸氨氯地平有关物质的反相高效液相色谱法。方法采用Diamonsil C18色谱柱(200 mm×4.6 mm,5μm)进行分离,流动相为甲醇-30 mmol/L磷酸二氢钾溶液(60∶40),流速1.0 mL/min,检测波长238 nm。结果所用色谱条件能很好地分离氨氯地平及其降解产物,氨氯地平质量浓度在0.71～3.57μg/mL范围内与峰面积线性关系良好。结论反相高效液相色谱法专属性强、准确、灵敏,可用于苯磺酸氨氯地平片中有关物质的检查。

Objective To establish a reversed-phase high performance liquid chro matography for the examination of related substances in Amlodipine Bensylate Tab lets.Methods A specific and stable RP-HPLC with ultraviolet detection was emplo yed.The chromatography was accomplished on Diamonsil C18 column（200 mm×4.6 mm,5 μm） and the mobile phase consisted of methanol-30 mmol/L potassium dihydro gen phosphate acid（60 ∶40）,the flow rate was 1.0 mL/min,detection wave length was set at 238 nm and the column temperature was maintained at room temperature.Results All the related substances gained a completely chromatographic separati on with the principal peak.A good relationship was observed in the concentration range of 0.71-3.57 μg/mL,with the correlation coefficient of 0.999 7.Conclu sion The method was proved to be highly specific,accurate and sensitive.It can be applied for the examination of the related substances in amlodipine besylate.