不同厂家瑞格列奈片中左旋异构体杂质含量检查

Detection of Levoisomer Impurities in Repaglinide Tablets from Different Manufacturers

目的考察不同厂家瑞格列奈片中左旋异构体杂质含量,为瑞格列奈片质量控制提供依据。方法采用《中国药典》2015年版瑞格列奈法定方法,大赛璐α1-酸性糖蛋白手性色谱柱(4.0mm×100mm,5μm);流动相:磷酸盐缓冲液为流动相A,乙腈为流动相B;流速1.0mL·min-1;梯度洗脱。检测波长2 4 0 n m;柱温30.0℃;进样量:20μL。结果与结论该色谱条件下,瑞格列奈与左旋异构体完全分离,该方法精密度高、专属性强,溶液24h内稳定,检查的4厂家9批次瑞格列奈片均未检出左旋异构体,均符合药典要求。

Objective To detect the levoisomer impurities in repaglinide tablets from different Manufacturers.Method A α 1-acid glycoprotein immobolised on 5 μm silica gel(4 mm×100mm,5μm)column was used,a phosphate buffer was used as mobile phase A,acetonitrile was used as mobile phase B,gradient elution,The flow rate was 1.0mL ·min^-1.The column temperature was 30.0℃;The detector wavelength was 240nm. The injection volume was 20 μL.Result and Conclusion repaglinide and levoisomer were separated completely under the chromatogram conditions,the method is accurate and specific,24 hours solution stability.From the analyzation of 9 batchs of repaglinide tablets of 4 manufacturers,none levoisomer were detected.The contents of levoisomer impurities of 9 batchs of repaglinide tablets were all meet the requirements of the pharmacopoeia.