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HPLC法测定苯磺酸氨氯地平片溶出度的研究

Dissolution of Amlodipine in Amlodipine Bensylate Tablets by HPLC
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摘要 目的 :建立高效液相色谱法同时测定几种规格苯磺酸氨氯地平片溶出度的方法。方法 :采用Agilent ZORBAX SB C18(150×4.6mm,5μm)色谱柱,流动相为甲醇-0.03mol/L磷酸二氢钾(70:30),流速为1.0ml·min-1;检测波长为237nm;柱温25℃。结果 :氨氯地平在0.003~0.0241mg/ml范围内,峰面积与浓度线性关系良好(r=0.9999),高、中、低六种浓度的平均加样回收率为98.3%-101.0%,RSD为0.60%。结论:方法准确、简便、快速,适用于多种规格苯磺酸氨氯地平片溶出度的测定。 Objective:To establish an HPLC method for dissolution of Amlodipine in Amlodipine Bensylate Tablets. Methods: Agilent ZORBAX SB CLs column(150×4.6mm,5μm)was used and the mobile phase consisted of MeOH-O.03mol/L KH2PO4(70:30) with a flow rate of 1.0 ml .min-E.The UV detection wavelength was set at 237nm.The column temperature was controlled at 25℃. Results:The calibration curve was linear (r=0.9999) within the range of 0.003-0.0241mg/ml for Amlodipine,the average recovery rates were from 98.3% to 101.0% for six different levels of the amount of Amlodipine,RSD was 0.60. Conclusion: This method was simple,quick,accurate and effective for dissolution of Amlodipine,It was suitable for the quality control for Amlodipine Bensylate Tablets.
出处 《科技视界》 2015年第15期273-274,共2页 Science & Technology Vision
关键词 苯磺酸氨氯地平片 氨氯地平 高效液相色谱法 溶出度 Amlodipine bensylate tablets Amlodipine HPLC Dissolution
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