奎尼丁原料和剂型中的二氢奎尼丁污染：高效液相色谱法快速测定

Dihydroquinidine contamination of quinidine raw materials and dosage forms: rapid estimation by high-performance liquid chromatography.

作者信息

Narang P K, Crouthamel W G

出版信息

J Pharm Sci. 1979 Jul;68(7):917-9. doi: 10.1002/jps.2600680739.

Abstract

Dihydroquinidine is a commonly encountered contaminant in quinidine raw materials. The USP allows 0-20% dihydroquinidine in quinidine products, but the assays used to quantitate dihydroquinidine have been lengthy or have required sophisticated equipment. The present method separates dihydroquinidine from quinidine and provides rapid, precise quantitation of both dihydroquinidine and quinidine. The clinical importance of dihydroquinidine contamination of quinidine dosage forms remains unanswered.

摘要

二氢奎尼丁是奎尼丁原料中常见的污染物。美国药典允许奎尼丁产品中二氢奎尼丁含量为0 - 20%，但用于定量二氢奎尼丁的分析方法耗时较长或需要精密设备。本方法可将二氢奎尼丁与奎尼丁分离，并能快速、准确地对二氢奎尼丁和奎尼丁进行定量。奎尼丁剂型中二氢奎尼丁污染的临床重要性仍未得到解答。