US EPA

7479430 

Journal Article 

Synthesis, isolation and characterization of efavirenz in-process impurity due to the presence of Tetrahydrofuran as solvent 

Saira, M; Nath, MR; Ramkrishana, KS; Sudesh, B; Krishnan, I 

2014 

1 

International Journal of Pharmacy and Pharmaceutical Sciences
ISSN: 2656-0097
EISSN: 0975-1491 

6 

1 

426-431 

English 

Objectives: The objective of this study is to synthesise and isolate in process impurity of Efavirenz in the presence of Tetrahydrofuran solvent. Method: In the process related impurity ranging from 0.05% to 0.2% in Efavirenz were detected by a gradient reversed phase high performance liquid chromatography (RP-HPLC).This impurity was isolated from the crude sample of Efavirenz using gradient reversed-phase preparative high performance liquid chromatography. Results: The unknown impurity of in process impurity of Efavirenz was synthesised and isolated by using the preparative chromatography of purity above 95%. The pure impurity was characterized by using IR, NMR, and MS spectral data and confirm the molecular structure of IUPAC name (4-Chlorobutyl)[4- Chloro-2(4-Cyclopropyl-1,1,1-Trifluro-but-3-yn-2-ol) Phenyl] Carbamate. Conclusion: The Efavirenz carbamate impurity was synthesized properly by using modern machineries. This is a work for the benefit of the human beings because impurity in the drugs can affect the human body. 

Characterization and synthesis; Efavirenz; Identification; Impurities; Spectroscopy; efavirenz; tetrahydrofuran; article; carbon nuclear magnetic resonance; drug determination; drug impurity; drug isolation; drug structure; drug synthesis; infrared spectroscopy; mass spectrometry; microwave radiation; proton nuclear magnetic resonance; reversed phase high performance liquid chromatography