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目的采用HPLC法测定复方苯磺酸氨氯地平胶囊的含量。方法采用Diamonsil C18色谱柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.03 mol.L-1磷酸二氢钾溶液(75:25),流速1.0 mL.min-1,检测波长238 nm。结果苯磺酸左旋氨氯地平0.25~500μg.mL-1与峰面积的线性关系良好(r=0.9999),平均回收率为99.6%(RSD=0.7%);辛伐他汀5.0μg.mL-1~1.0 mg.mL-1与峰面积的线性关系良好(r=0.9999),平均回收率为99.9%(RSD=0.6%)。结论所建方法准确、简便、快速,可用作复方苯磺酸氨氯地平胶囊的含量测定方法 。
Objective To determine the content of amlodipine besylate by HPLC. Methods Diamonsil C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase was methanol-0.03 mol·L-1 potassium dihydrogen phosphate solution (75:25) at a flow rate of 1.0 mL · min- . Results The linear range of 0.25 ~ 500μg · mL-1 levamlodipine besylate was good (r = 0.9999) with an average recovery of 99.6% (RSD = 0.7%). Simvastatin 5.0μg.mL-1 The linear relationship between ~ 1.0 mg.mL-1 and peak area was good (r = 0.9999). The average recovery was 99.9% (RSD = 0.6%). Conclusion The established method is accurate, simple and rapid and can be used as a method for the determination of amlodipine besylate capsules.