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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 establish a HPLC method for determination of amlodipine maleate dispersible tablets in the main drug and related substances. Methods: Lichrospher C18 was used as the mobile phase. The mobile phase consisted of methanol-0.03 mol · Lℓ-1 potassium phosphate monobasic (70:30), the detection wavelength was 237 nm, the flow rate was 1 mL · min-1 and the column temperature was 30 ℃. Results: The linear range of amlodipine maleate was 31.94 ~ 127.75μg · mL-1 (r = 0.9998, n = 5) with the average recovery of 99.5% (RSD = 0.39%, n = 9) Related substances are less than 0.38%. Conclusion: The method is simple, rapid, accurate and specific and suitable for the quality control of amlodipine maleate dispersible tablets.