苯磺酸左旋氨氯地平片中右旋杂质的检查

目的用磺丁基醚-β-环糊精(SBE-β-CD)作为手性选择剂,建立苯磺酸左旋氨氯地平片中右旋杂质的HPLC检查方法。方法色谱柱:Hypersil BDS C8柱(200mm×4.6mm,5μm);流动相:25mmol.L-1SBE-β-CD水溶液(pH2.5)-甲醇(55∶45);流速0.8mL·min-1;检测波长:360nm,进样量:20μL,柱温:20℃。结果苯磺酸右旋氨氯地平在1.0~2.0μg.mL-1范围内线性关系良好,r=0.9996,平均回收率为99.3%,RSD为1.9%。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中右旋杂质的检查。

Enantiomeric impurity determination of Levamlodipine Besylate Tablets

Objective To investigate the determination method of enantiomeric impurity of levamlodipine besylate tablets using reversed phase high performance liquid chromatography with sulfobutylether-β-cyclodextrin as the chiral mobile phase additive.Methods Separation was performed on an Hypersil BDS C8 column（200 mm ×4.6 mm,5 μm）with mobile phase composed of water（pH 2.5,containing 25 mmol·L-1 sulfobutylether-β-cyclodextrin）-methanol（55∶45）.The flow rate was 0.8 mL·min-1 and the detection wavelength was set at 360 nm.Results The calibrated linear curve of dextro-amlodipine besylate was within 1.0～2.0 μg·mL-1（r=0.999 6）.The average recovery was 99.3% with RSD of 1.9%.Conclusion The method is proved to be accurate and reliable.It could be used for the determination of the enantiomeric impurity of Levamlodipine Besylate Tablets.