Determination of minor impurities of (R)-1-acetoxymethyl-3-(7-[(1-N,N-dimethylcarbamoyl)-6-(4-fluorophenyl)-indol-3-oyl]-1H,3H-pyrrolo[1,2-c]thiazol-3-yl)pyridinium chloride by high performance liquid chromatography

被引：5
|
作者：
Golich, TG
Thomsen, JR
Green, DL
Jersild, J
机构：
[1] PPD Analytical Research Department, Abbott Laboratories, North Chicago, Illinois
来源：
JOURNAL OF LIQUID CHROMATOGRAPHY | 1995年 / 18卷 / 20期
关键词：
D O I：
10.1080/10826079508013748
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
Minor impurities of (R)-1-acetoxymethyl-3-(7-[(1-N,N-dimethylcarbamoyl)-6-(4-fluorophenyl)-indol-3-oyl]-1H,3H-pyrrolo[1,2-c]thiazol-3-yl)pyridinium chloride (I), a pro-drug, were determined using highperformance liquid chromatography. Manufacturing impurities, degradation products, and active drug, (R)-7-[(1-N,N-dimethylcarbamoyl)-6-(4-fluorophenyl)-indol-3-oyl] -1H,3H-pyrrolo[1,2-c]thiazole (II) were separated using a reversed-phase system with gradient elution. Detector response was linear for II to approximately 470 mu g/mL which represents 47% of the drug concentration. The procedure provides relative standard deviations of 3.0% to 13.2% in typical bulk drug lots. A variety of reversed-phased columns were evaluated for the assay method with the optimum resolution achieved using a 5-mu m Zorbax Rx C-8 packing.
引用
收藏
页码：4107 / 4116
页数：10
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