Efavirenz related compounds preparation by hydrolysis procedure: Setting reference standards for chromatographic purity analysis

被引：15

作者：

de Aquino Ribeiro, Jose Antonio ^{[1
]}

Moreira de Campos, Ligia Maria ^{[1
]}

Alves, Ricardo Jose ^{[1
]}

Lages, Gustavo Portela ^{[1
]}

Pianetti, Gerson Antonio ^{[1
]}

机构：

[1] Univ Fed Minas Gerais, Fac Farm, Dept Prod Farmaceut, BR-31270910 Belo Horizonte, MG, Brazil

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2007年 / 43卷 / 01期

关键词：

efavirenz; degradation; related compounds; chromatographic purity;

D O I：

10.1016/j.jpba.2006.06.010

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A simple procedure for obtaining and purifying two degradation products of efavirenz (amino alcohol and quinoline derivatives) from drug substance hydrolysis is described. These impurities are known to exhibit very different UV absorbance properties from those of the parent compound, making determination using a quantitation factor (QF) inaccurate. The obtained hydrolysis products were characterized by physicochemical methods to assure identity, purity and strength. Quinoline derivative was of high purity degree (100%) and amino alcohol was 98.74% pure. Both were set as reference standards in chromatographic related compounds test for efavirenz drug substance and tablets analyses. (c) 2006 Elsevier B.V. All rights reserved.

引用

页码：298 / 303

页数：6

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