苯磺酸左旋氨氯地平片光学纯度检查研究

Research on Optical Purity Test in Levamlodipine Besylate Tablets

目的建立高效液相色谱法测定苯磺酸左旋氨氯地平片光学纯度的检查方法。方法采用ULTRON ES-OVM手性柱（2.0 mm×150 mm,5μm）,乙腈-0.02 mol·L-1磷酸氢二钠水溶液（pH 7.0）（20∶80）为流动相,流速为0.8mL·min-1,检测波长为360nm,进样量为20μL,柱温为室温。结果苯磺酸左旋氨氯地平在50.25~402μg·mL-1（r=0.9999）范围内线性关系良好;检测限为40.6ng（S/N=3）。结论该方法专属性强、重复性好、结果准确,可用于苯磺酸左旋氨氯地平片光学纯度的检查。

Objective To establish an HPLC method for the determination of optical purity in levamlodipine besylate tablets.Methods An ULTRON ES-OVM chiral column（2.0 mm×150 mm, 5μm）was used.The mobile phase consisted of acetonitrile-0.02mol·L-1 two aqueous solution of sodium hydrogen phosphate（pH 7.0）（20∶80）with the flow rate 0.8mL·min-1.The detection wavelength was 360nm and the injected volume was 20μL,with column temperature at room temperature.Results Levamlodipine besylate showed a good linear relationship at the linear range of 50.25-402μg·mL-1（r= 0.9999）,and the detective limit was 40.6 ng（S/N =3）.Conclusion The method has a strong specificity,repeatability and accuracy and can be used for the optical purity check in levamlodipine besylate tablets.