反相高效液相色谱法测定苯磺酸氨氯地平胶囊的含量和有关物质

Determination of Contents and Related Substances in Amlodipine Besylate Capsules by RP-HPLC

目的建立测定苯磺酸氨氯地平胶囊中苯磺酸氨氯地平含量及有关物质的反相高效液相色谱(RP-HPLC)法。方法采用HypersilBDS柱(200 mm×4.6 mm,5μm),以0.01 mol/L磷酸氢二钾溶液(含0.7%三乙胺,磷酸调pH=4.0±0.1)-乙腈(70∶30)为流动相,流速为1.0 mL/min,柱温为30℃,检测波长237 nm。结果苯磺酸氨氯地平峰和相邻杂质峰可达到有效分离(R>1.5)。苯磺酸氨氯地平质量浓度在5.0～50.0μg/mL范围内与峰面积线性关系良好(r=0.999 9,n=5);低、中、高3种质量浓度的平均回收率分别为99.17%,100.03%,99.85%,RSD分别为1.21%,0.87%,1.06%(n=3);方法的精密度和重复性良好,RSD均小于2%。结论该方法准确、简便、快速,适用于苯磺酸氨氯地平胶囊的质量控制。

Objective To establish a RP-HPLC method for determining the amlodipine besylate content and the related substances in Amlodipine Besylate Capsules.Methods The Hypersil BDS column（200 mm×4.6 mm,5 μm）was adopted with UV detection wavelength at 237 nm.The mobile phase consisted of 0.01 mol/L K2HPO4 buffer solution（containing 0.7%triethylamine,adjusting to pH 4.0±0.1 with phosphoric acid）-acetonitrile（70 ∶30）.The flow rate was 1.0 mL/min and the column temperature was 30 ℃.Results Amlodipine besylate was separated from its related substances thoroughly（R 1.5）.The calibrated linear curve of amlodipine besylate was within 5.0-50.0 μg/mL（r=0.999 9,n=5）.The average recovery rates of high,middle and low mass concentrations were 99.17%,100.03%and 99.85%with RSD of 1.21%,0.87%and 1.06%,respectively.The reproducibility and precision of the method were good（RSD 2%）.Conclusion This method is accurate,simple and quick,which is suitable for the quality control of Amlodipine Besylate Capsules.