摘要
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 an HPLC method for the content determination of levamlodipine besylate tablets and enantio- meric impurity with sulfobuty lether-β-cyclodextrin as the chiral mobile phase additive. Methods： An Agilent Eclipse XDB-C1s column （ 250 mm × 4.6 mm, 5 μm） was adopted for the HPLC analysis, the mobile phase was 0.01 tool · L- i phosphate buffer solution （ con- mining 0.01 mol· L-1 sulfobuty lether-β-cyclodextrin） - methanol （60：40） with a flow rate of 0.8 ml · min-l; the detection wave- length was 360 nm, the column temperature was at 30℃, and the injection volume was 10 μl. Results： The linear range of chondroitin sulfate sodium was 5.0-251.0 μg · ml-l（r=0.999 7）, and the average recovery was 100.31% （RSD =0.9%, n = 9）. The detec- tion limit was 16ng. Levamlodipine besylate tablets and enantiomeric impurity could he well separated. Conclusion： The method is simple, rapid and accurate, and suitable for the content determination of levamlodipine besylate tablets and enantiomeric imourity.
出处
《中国药师》
CAS
2015年第9期1516-1518,共3页
China Pharmacist
