PİPERİDİNYUM 2-((5-(FURAN-2-İL)-4-FENİL-4H-1,2,4-TRİAZOL)-3-İL) ASETATIN ZORLANMIŞ BOZUNMA ÇALIŞMASI

Amaç: Bu araştırmanın amacı; aktif farmasötik içerikteki (API) 2-((5-(furan-2-İl)-4-fenİl-4H-1,2,4-trİazol)-3-İl) asetat maddesinin % 0.1 çözeltisinin ve enjeksiyonluk % 1 çözeltisinin zorlanmış bozunmasının incelenmesidir. Çalışma, sodyum hidroksit, hidroklorik asit,% 3 H2O2, sıcaklık ve UV radyasyonunda bulunan piperidinyum 2–((5-(furan-2-il)-4-fenil-4H-1,2,4-triazol)-3-il) asetatın % 0.1 çözelti ve enjeksiyonluk % 1'lik çözeltisinde gerçekleştirilmiştir. Gereç ve Yöntem: Agilent 1260 Infinity HPLC Sistemi. Agilent dört kutuplu kütle spektrometresi 6120. Sonuç ve Tartışma: Piperidinyum 2-((5-(furan-2-il)-4-fenil-4H-1,2,4-triazol)-3-il) asetatın kantitatif içeriğinin, maruz kalma süresine bağlı olduğu belirlenmiştir. Oksitleyicinin (% 3 Н2О2) etkisi altında oluşan bozunma ürünlerinin bileşimi gösterilmiştir. UV radyasyonunun etkisi altında oluşan bozunma ürünlerinin bileşimi önerilmiştir.

Anahtar Kelimeler:

ESI kütle spektrometresi, triazoller, yüksek basınçlı sıvı kromatografisi, zorlanmış bozunma çalışması

PIPERIDINIUM 2-((5-(FURAN-2-YL)-4-PHENYL-4H-1,2,4-TRIAZOL)-3-YL) ACETATE FORCED DEGRADATION STUDY

Objective: Aim of the research to make forced degradation study of piperidinium 2-((5- (furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl) acetate in active pharmaceutical ingredient (API), 0.1% solution and 1% solution for injection. Influence of the sodium hydroxide, hydrochloride acid, 3% Н2О2, temperature, UV radiation on piperidine 2-((5-(furan-2-yl) -4-phenyl-4H-1,2,4-triazol-3-yl) acetate substance, 0.1% solution and 1% solution for injections was studied. Material and method: Agilent 1260 Infinity HPLC System. Agilent single-quadrupole mass spectrometer 6120. Result and discussion: Dependence of the quantitative content of the piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl) acetate from exposition time was determined. The composition of impurities formed under the action of an oxidizer was established (3%Н2О2). This is sulfoxide and sulfone corresponding to the API. The composition of impurities which were formed under the influence of UV radiation was proposed.

Keywords:

ESI mass spectrometry, forced degradation stuy, high pressure liquid chromatography, triazoles,

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