TY - JOUR T1 - PIPERIDINIUM 2-((5-(FURAN-2-YL)-4-PHENYL-4H-1,2,4-TRIAZOL)-3- YL) ACETATE FORCED DEGRADATION STUDY TT - PİPERİDİNYUM 2-((5-(FURAN-2-İL)-4-FENİL-4H-1,2,4-TRİAZOL)-3-İL) ASETATIN ZORLANMIŞ BOZUNMA ÇALIŞMASI AU - Varynskyi, Borys PY - 2019 DA - June Y2 - 2019 DO - 10.33483/jfpau.480073 JF - Journal of Faculty of Pharmacy of Ankara University JO - J. Fac. Pharm. Ankara PB - Ankara Üniversitesi WT - DergiPark SN - 1015-3918 SP - 117 EP - 134 VL - 43 IS - 2 LA - en AB - Objective: Aim of the research to make forced degradation study of piperidinium2-((5- (furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl) acetate in active pharmaceuticalingredient (API), 0.1% solution and 1% solution for injection. Influence ofthe 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. Resultand discussion: Dependence of the quantitative content of the piperidinium2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl) acetate from exposition timewas determined. The composition of impurities formed under the action of an oxidizer wasestablished (3%Н2О2). This is sulfoxide and sulfonecorresponding to the API. The composition of impurities which were formed under the influence of UVradiation was proposed. KW - ESI mass spectrometry KW - forced degradation stuy KW - high pressure liquid chromatography KW - triazoles N2 - 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 çözeltisininzorlanmış bozunmasının incelenmesidir. Çalışma, sodyum hidroksit, hidroklorikasit,% 3 H2O2, sıcaklık ve UV radyasyonunda bulunan piperidinyum2–((5-(furan-2-il)-4-fenil-4H-1,2,4-triazol)-3-il) asetatın % 0.1 çözelti veenjeksiyonluk % 1'lik çözeltisinde gerçekleştirilmiştir.Gereç ve Yöntem: Agilent 1260 Infinity HPLC Sistemi. Agilent dört kutuplu kütlespektrometresi 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 olduğubelirlenmiştir. Oksitleyicinin (% 3 Н2О2) etkisi altındaoluşan bozunma ürünlerinin bileşimi gösterilmiştir. UV radyasyonunun etkisi altında oluşan bozunmaürünlerinin bileşimi önerilmiştir. CR - Sehrawat, R., Maithani, M., Singh, R. (2010). Regulatory Aspects in Development of Stability-Indicating Methods: A Review. Chromatographia, 72 (1/2), 1–6. CR - Blessy, M, Ruchi, D. P., Prajesh, N. Pr., Agrawal Y.K. (2014). Development of forced degradation and stability indicating studies of drugs—A review. Journal of Pharmaceutical Analysis; 4(3), 159–165. CR - Klick, S., Muijselaar, P. G., Waterval J., Eichinger, Th., Korn, C., Gerding Th. K., Debets Al. J., Van de Griend C. S., Van den Beld C., Somsen G. W. and De Jong G. J. (2005). Stress Testing of Drug Substances and Drug Products. Pharmaceutical Technology, FEBRUARY; 48–66. CR - Chakravarthy, V. A., Sailaja, B. B. V., Kumar A. P. (2015). Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms. Journal of Analytical Methods in Chemistry, 1 – 11 CR - Ahirrao, V. K., Patil, C. S., Bembalkar, S. R., Katariya, M. V., Sonnekar, V. S., Marathe, R. P., Nawale, R. B., Pawar, R. P. (2012). Stress degradation studies of dronedarone in pharmaceutical dosage form by a validated stability-indicating LC method. Journal of the Chilean Chemical Society,57(3); 1272 – 1276. CR - Patel, J. K., Patel, N. K. (2014). Stability-Indicating RP-HPLC Method for the Determination of Ambrisentan and Tadalafil in Pharmaceutical Dosage Form. Scientia Pharmaceutica, 82, 749–763 CR - Parchenko, V. (2006). Synthesis, physicochemical and biological properties of derivatives of 1,2,4-triazoles-3-thione containing core furan. Candidate of PharmSci thesis, Zaporozhye State Medical University, Zaporozhye, 208 p. CR - Parchenko, V. (2014). Synthesis, transformation, physico-chemical and biological properties in a number of 5-furyl-substituted 1,2,4-triazole-3-thiones. Dr. Pharmacist Sciences thesis, Zaporozhye State Medical University, Zaporozhye, 460 p. CR - Tietze, L.F., Eicher, Th. (1991). Reaktionen und Synthesen im organisch‐chemischen Praktikum und Forschungslaboratorium. 2. Aufl., Georg Thieme Verlag, Stuttgart – New York. DM 68, 672 S. CR - Varynskyi, B. O. (2016). Optimization of the detection conditions for the series of 1,2,4-triazole-3-thiones for FIA-ESI-MS and HPLC-ESI-MS. NEWS OF PHARMACY, 1(85), 7-11. UR - https://doi.org/10.33483/jfpau.480073 L1 - https://dergipark.org.tr/tr/download/article-file/729673 ER -