HPLC测定阿卡波糖胶囊的含量及有关物质

Determination of content and related substances of Acarbose capsules by HPLC

目的 建立测定阿卡波糖胶囊含量及有关物质的方法。方法 采用HPLC法 ,LichrospherNH2 色谱柱 (4 .6mm× 2 5 0mm ,5 μm) ,以乙腈 -磷酸盐缓冲液 (72∶2 8)为流动相 ,流速 1.3ml·min-1,检测波长 2 10nm。结果 阿卡波糖在浓度为 0 .6～1.2mg·ml-1范围内线性关系良好 (r=0 .9999) ,平均回收率为 10 0 .6 3% ,样品溶液在 2 4h内稳定 ,最低检测限为 0 .0 8μg。 结论 所用方法简便、重复性好 ,结果准确。

OBJECTIVE To establish a method to determine the content and related substances of Acarbose capsules.METHODS HPLC method was adopted with Lichrospher NH 2 column(5 μm,4.6 mm×250 mm);The mobile phase was acetonitrile-phosphate buffer (72∶28).The flow rate was 1.3 ml·min -1.The detective wavelength was at 210 nm.RESULTS The calibration curve was linear in the concentration range of 0.6-1.2 mg·ml -1(r=0.9999).The average recovery was 100.63%.The sample solution was stable in 24 h.The limit of detection is 0.08 μg.CONCLUSION The method is simple,rapid,accurate and reliable.