摘要
Abstract
Objective To establish a RP - HPLC method for determining the amlodipine besylate content and the related suhstances 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 huffer 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. 2l％ , 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.关键词
高效液相色谱法/苯磺酸氨氯地平/含量测定/有关物质Key words
HPLC/ amlodipine besylate/ content determination/ related substances分类
医药卫生
