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

Year 2019, , 117 - 134, 01.06.2019

Borys Varynskyi

https://doi.org/10.33483/jfpau.480073

Abstract

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

Thanks

We acknowledge complete support of the Zaporozhye State Medical University. We thank rector of Zaporozhye State Medical University Prof. Yu. M. Kolesnyk for his help and support.

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

Abstract

        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.    

Keywords

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

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