国产多潘立酮原料及其片剂有关物质现状观察王戈1,2   刘英慧2  袁波1  (1.沈阳药科大学药学院  沈阳 110016；2.大连市食品药品检验所)

国产多潘立酮原料及其片剂有关物质现状观察王戈1,2 刘英慧2 袁波1 (1.沈阳药科大学药学院沈阳 110016；2.大连市食品药品检验所)

王戈,刘英慧,袁波

大连市食品药品检验所,大连市食品药品检验所,沈阳药科大学药学院

收稿日期:2013-04-12 修回日期:2013-04-21 出版日期:2013-04-25 发布日期:2013-04-25

The Survey of related substances in Domperidone raw materials and Domperidone TabletsWang Ge1,2 , Liu Yinghui2, Yuanbo1(1. Shenyang Pharmaceutics University, Shengyang 110016; 2 Dalian Institute for Food and Drug Control)

wangge,liuyinghui and yuanbo

Dalian Institute of food and drug control,Dalian Institute of food and drug control,Shenyang Pharmaceutical University

Received:2013-04-12 Revised:2013-04-21 Online:2013-04-25 Published:2013-04-25

摘要/Abstract

摘要： 目的：对多潘立酮原料及片剂的有关物质进行测定。方法：参照原研厂家标准设计试验,色谱柱为Aglient TC C18(250 mm?4.6 mm,5μm)；流动相为0.5%乙酸铵溶液-乙腈,采用梯度洗脱法,流速为1.0ml/min；检测波长：280nm。结果：15批原料中均检出杂质R029676和杂质R052211,21批多潘立酮片中均检出杂质R029676和杂质R052211,其中17个企业的样品检出杂质R099527。结论：多潘立酮原料中检出两种已知杂质,多潘立酮片中检出三种已知杂质。

Abstract: Objective: To determine the related substances of Domperidone raw materials and Domperidone Tablets. Methods: The methods was investigated according to the standards of manufacture factory. Aglient TC C18 column(250 mm×4.6 mm,5μm) was used. The mobile phase consisted of 0.5% ammonium-acetonitrile. The flow rate was 1.0ml/min and the detection wavelenghth was 280nm. Results: Impurity R029676 and R052211 was found in 15 batches raw materials. Impurity R029676 and R052211 was found in all 21 batches domperidone tablets and impurity R099527 was found in 17 batches. Conclusion: Two impurities were found in domperidone raw materials while three were found in domperidone tablets.

王戈,刘英慧,袁波. 国产多潘立酮原料及其片剂有关物质现状观察王戈1,2 刘英慧2 袁波1 (1.沈阳药科大学药学院沈阳 110016；2.大连市食品药品检验所)[J]. .

wangge,liuyinghui and yuanbo. The Survey of related substances in Domperidone raw materials and Domperidone TabletsWang Ge1,2 , Liu Yinghui2, Yuanbo1(1. Shenyang Pharmaceutics University, Shengyang 110016; 2 Dalian Institute for Food and Drug Control)[J]. .