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

作者信息

Ribeiro José Antônio de Aquino, de Campos Ligia Maria Moreira, Alves Ricardo José, Lages Gustavo Portela, Pianetti Gerson Antônio

机构信息

Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos 6627, 31270-910, Belo Horizonte, MG, Brazil.

出版信息

J Pharm Biomed Anal. 2007 Jan 4;43(1):298-303. doi: 10.1016/j.jpba.2006.06.010. Epub 2006 Jul 18.

DOI:10.1016/j.jpba.2006.06.010

PMID:16854550

Abstract

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.

摘要