HPLC法测定依帕司他片清洁验证中残留物

Determination of Residues in Cleaning Validation of Epalrestat Tablets by HPLC

采用高效液相色谱法测定制剂大生产过程中依帕司他片的主成分残留量。对316L不锈钢、聚四氟乙烯、有机玻璃和硅胶四种材质进行清洁验证,用高效液相色谱于294 nm处,流动相为磷酸盐缓冲液-乙腈(体积比=65∶35),进行检测。结果表明,质量浓度在0.0031~3.6800μg/mL范围内呈现良好的线性关系,相关系数R为1.000,回收率为83%~91%。该方法快速、准确,专属性和特征性高,操作简便,适用于依帕司他片清洁验证中残留物的分析。

High-performance liquid chromatography was used to determine the residual amount of the main component of epalrestat tablets during the mass production of the preparation.Cleaning validation is used for four materials:316L stainless steel,PTFE,plexiglass and silicone.The experiment was carried out by high performance liquid chromatography at 294 nm and the mobile phase was phosphate buffer-acetonitrile(volume ratio=65∶35).The results showed that the mass concentration showed a good linear relationship in the range of 0.0031-3.6800μg/mL,the correlation coeff icient R was 1.000,and the recovery rate was 83%~91%.The method is fast,accurate,highly specif ic and characteristic,and easy to operate.It is suitable for the analysis of residues in the cleaning validation of epalrestat tablets.