IMPURITY PROFILING OF FIRST LINE ANTI-TB DRUG-TERIZIDONE USING CHROMATOGRAPHIC AND RELATED TECHNIQUES
Tuberculosis is the bacterial infection spread through Mycobacterium tuberculosis since more than 50years. In 2019, 1.21 Million deaths were reported worldwide due to TB infection. Terizidone (TRZ) is listed as first line medicine for treatment of TB and as an essential medicine by WHO (World Health Organization). The study reveals about stability holding capacity of TRZ against different stress degradation conditions. The stability study was completed using HPLC instrument with 0.01M ammonium acetate buffer (pH 4.0 using glacial acetic acid (GAA)) and acetonitrile in gradient program. The stress degradation study was completed in hydrolytic solution, oxidized solution, under thermal and under UV (Ultraviolet) light among which TRZ degraded in hydrolytic solutions (acid, alkali and water) and oxidized solution while it was stable in other conditions. The degradation products (DPs) were identified using UPLC (Ultra Performance Liquid Chromatography) and ESI/MS. Major degradation products were isolated using preparative HPLC. In acid, neutral and oxidative medium, the numbers of DPs formed are 7, 9 and 10, respectively. The complete Impurity profiling for TRZ is reported for the first time in literature. The study data would be add-on for formulation storage condition and further development.
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