HPLC法测定马来酸氨氯地平分散片中主药及有关物质含量

Content Determination of Main Component and Related Substances in Amlodipine Maleate Dispersible Tablets by HPLC

目的:建立以高效液相色谱法测定马来酸氨氯地平分散片中主药及有关物质含量的方法。方法:采用LichrospherC18为色谱柱,以甲醇-0.03mo·lL-1磷酸二氢钾(70∶30)为流动相,检测波长为237nm,流速为1mL·min-1,柱温为30℃。结果:马来酸氨氯地平检测浓度线性范围为31.94～127.75μg·mL-1(r=0.9998,n=5),平均回收率为99.5%(RSD=0.39%,n=9);样品中有关物质含量均小于0.38%。结论:该方法简便、快速、准确、专属性好,适于马来酸氨氯地平分散片的质量控制。

OBJECTIVE： To established an HPLC method for the determination of main component and related substances in amlodipine maleate dispersible tablets. METHODS： The separation was performed on a Lichrospher C18 column. The mobile phase consisted of methanol-0.03 mol？L-1 potassium dihydrogen phosphate （70 ∶ 30） at the flow rate of 1 mL·min-1. The detection wavelength was set at 237 nm and column temperature was 30 ℃. RESULTS： The linear range of amlodipine maleate were 31.94～127.75 μg·mL-1 （r=0.999 8, n=5）. The average recovery was 99.5% （RSD=0.39%, n=9）. The contents of related substance were all lower than 0.38%. CONCLUSION： The method is simple, rapid, accurate and specific for the quality control of amlodipine maleate dispersible tablets.