清洁验证中二氢吡啶类药物残留的流动注射化学发光法测定  

Determination of Residual Dihydropyridine Drugs on Cleaning Validation by Flow Injection Chemiluminescence

作　　者：田怀茹 景绍君 倪美萍[2] 周如君 蒋晔[1] 

机构地区：[1]河北医科大学药学院,河北石家庄050017 [2]中国医药工业研究总院药物制剂国家工程研究中心,上海200437 [3]冀中能源邢台矿业集团总医院药剂科,河北邢台054000

出　　处：《中国医药工业杂志》2014年第8期776-778,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了流动注射化学发光法测定清洁验证过程中二氢吡啶类药物（尼群地平、尼莫地平、非洛地平和间尼索地平）残留量.上述二氢吡啶类药物在0.2～4 μ,g/ml范围内线性关系良好,最低检测限为0.03～0.06 μg/ml.平均回收率为96.3％～100.9％,RSD＜3.6％.A flow injection chemiluminescence （CL） method was established for the determination of dihydropyridine drugs on cleaning validation, including nitrendipine, nimodipine, felodipine, and m-nisoldipine. The calibration curves for the above dihydropyridines were linear in the concentration range of 0.2 - 4 μg/ml. Their low limits of detection were 0.03 - 0.06 μg/ml. The average recoveries were 96.3 % - 100.9 %, with RSDs less than 3.6 %.

关 键 词：二氢吡啶类药物 清洁验证 流动注射化学发光法 测定 

分 类 号：R917[医药卫生—药物分析学]