高效液相色谱法测定苯磺酸氨氯地平的含量

Content Determination of Amlodipine Besylate by RP-HPLC

目的建立药物中苯磺酸氨氯地平的含量测定的方法。方法采用高效液相色谱法,色谱柱为Wonda Sil C18柱（150 mm×4.6 mm,5μm）,流动相为甲醇-0.03 mol/L乙酸铵溶液（70∶30）,流速为0.8 mL/min,柱温为室温,检测波长为237 nm。结果苯磺酸氨氯地平质量浓度在2-1 000μg/mL范围内与峰面积线性关系良好（r=0.999 9）。平均加样回收率为99.49%,RSD为1.35%（n=9）。结论该方法简便、准确、线性范围宽,重复性好,可作为药物中苯磺酸氨氯地平含量测定的方法。

Objective To establish a RP- HPLC method for the content determination of amlodipine besylate in drugs. Methods The analysis was accomplished on the Wonda Sil C18 column（ 150 mm × 4. 6 mm, 5 μm）, with the mobile phase of methanol- 0. 03 mol / L ammonium acetate solution（ 70 ∶ 30）, at room temperature, the UV detection wavelength of 237 nm and a flow rate of 0. 8 mL / min.Results Amlodipine besylate in the concentration range of 2- 1 000 μg / mL exhibited a good linear relationship with the peak area（ r = 0. 999 9）. The average recovery rate of the sample size was 99. 49%, RSD = 1. 35%（ n = 9）. Conclusion This method is simple and accurate with wide linear range and good reproducibility,and can be used to determine the content of amlodipine besylate in drugs.