论文部分内容阅读
目的:用磺丁基醚-β-环糊精(SBE-β-CD)为手性选择剂,建立测定苯磺酸左旋氨氯地平片的含量及其右旋杂质的高效液相色谱法。方法:采用Agilent Eclipse XDB-C18色谱柱(250 mm×4.6 mm,5μm),流动相为含0.02 mol·L-1SBE-β-CD的0.01 mol·L-1磷酸二氢钾溶液-甲醇(60∶40),流速0.8 ml·min-1,检测波长360 nm,柱温30℃,进样量10μl。结果:苯磺酸左旋氨氯地平在5.0~251.0μg·ml-1范围内线性关系良好(r=0.999 7),平均回收率为100.31%(RSD=0.9%,n=9),检测限为16 ng,苯磺酸左旋氨氯地平与其右旋杂质分离度良好。结论:本方法简便、快速、准确,专属性好,可用于测定苯磺酸左旋氨氯地平片的含量及其右旋杂质。
OBJECTIVE: To establish a HPLC method for determination of levoamlodipine besylate and its dextrorotatory impurity by using sulfobutyl ether-β-cyclodextrin (SBE-β-CD) as a chiral selective agent. Methods: An Agilent Eclipse XDB-C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 0.01 mol·L-1 potassium dihydrogen phosphate solution containing 0.02 mol·L-1 SBE- : 40), flow rate 0.8 ml · min-1, detection wavelength 360 nm, column temperature 30 ℃, injection volume 10μl. Results: L-amlodipine besylate showed good linearity (r = 0.999 7) in the range of 5.0 ~ 251.0μg · ml-1 with an average recovery of 100.31% (RSD = 0.9%, n = 9) 16 ng, levamlodipine besylate and its right-handed impurity separation is good. Conclusion: The method is simple, rapid, accurate and specific. It can be used to determine the content of L-amlodipine besylate and its right-handed impurity.