Efavirenz related compounds preparation by hydrolysis procedure: setting reference standards for chromatographic purity analysis.
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.
Ribeiro
José Antônio de Aquino
JA
Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos 6627, 31270-910, Belo Horizonte, MG, Brazil. josedeaquino@farmacia.ufmg.br
de Campos
Ligia Maria Moreira
LM
Alves
Ricardo José
RJ
Lages
Gustavo Portela
GP
Pianetti
Gerson Antônio
GA
D000480:Alkynes; D000605:Amino Alcohols / Q000032:analysis; D019380:Anti-HIV Agents / Q000032:analysis*; D048588:Benzoxazines; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D002855:Chromatography, Thin Layer; D003521:Cyclopropanes; D006868:Hydrolysis; D009682:Magnetic Resonance Spectroscopy; D010078:Oxazines / Q000032:analysis*; D011804:Quinolines / Q000032:analysis; D012015:Reference Standards; D012044:Regression Analysis; D013055:Spectrophotometry, Infrared; D013607:Tablets
D000480:Alkynes; D000605:Amino Alcohols; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; D011804:Quinolines; D013607:Tablets; C098320:efavirenz