IDENTIFICATION AND QUANTITATION OF IMPURITIES IN METHOTREXATE

被引：18

作者：

CHATTERJI, DC ^{[1
]}

FRAZIER, AG ^{[1
]}

GALLELLI, JF ^{[1
]}

机构：

[1] NIH,CTR CLIN,DEPT PHARM,BETHESDA,MD 20014

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 1978年 / 67卷 / 05期

关键词：

Antineoplastic agents—methotrexate; chromatographic separation; UV; NMR; and mass spectral analyses of impurities in various formulations; Impurities—in various formulations of methotrexate; and mass spectral analyses; Methotrexate—chromatographic separation;

D O I：

10.1002/jps.2600670512

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

The impurities in bulk, commercial, and investigational methotrexate samples were chromatographically separated by gradient elution from a diethylaminoethylcellulose column. Besides the already known impurities in the bulk and commercial samples, two other impurities, 4‐amino‐N10‐methylpteroyl‐N‐methylglutamine and 2,4‐diamino‐N10‐methylpteramide, were identified. A new batch of methotrexate, synthesized for the National Cancer Institute for investigational use only, showed a different spectrum of impurities. The purity of all methotrexate samples studied was about 86% calculated on an anhydrous basis. Copyright © 1978 Wiley‐Liss, Inc., A Wiley Company

引用

页码：622 / 624

页数：3

共 9 条

[1] HIGH-PRESSURE LIQUID-CHROMATOGRAPHIC ANALYSIS OF METHOTREXATE IN PRESENCE OF ITS DEGRADATION PRODUCTS [J].