Development and validation of HPLC-DAD method of determination piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetate in 1 % solution

Authors

  • B. O. Varynskyi Zaporizhzhia State Medical University, Ukraine,
  • V. V. Parchenko Zaporizhzhia State Medical University, Ukraine,
  • А. G. Kaplaushenko Zaporizhzhia State Medical University, Ukraine,

DOI:

https://doi.org/10.14739/2310-1210.2017.6.115313

Keywords:

triazoles, high pressure liquid chromatography, pharmaceutical products, veterinary drugs

Abstract

Purpose. The purpose of this research is to develop new, highly sensitive and selective method for determination of piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetate as an active pharmaceutical ingredient (API) in 1 % injection solution based on high performance liquid chromatography with diode-array detection.

Materials and methods. LC System was Agilent 1260 Infinity (degasser, binary pump, autosampler, thermostatted column compartment, diode array detector). Single quadrupole mass spectrometer Agilent 6120 with ionization in electrospray (ESI). Open LAB CDS Software. Column was Zorbax SB-C18; 30 mm × 4.6 mm; 1.8 µm. Injection volume was 2 µL. Isocratic mode. The mobile phase was water/acetonitrile (70:30) with 0.1 % methanoate acid. Standard samples were piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetate, furan-2-carbohydrazide, 2-(furan-2-carbonyl)-N-phenylhydrazine-1-carbothioamide, 5-(furan-2-yl)-4-phenyl-2,4-dihydro-3H-1,2,4-triazole-3-thione.

Results. The graphs of the capacity factor from the acetonitrile concentration dependence in the mobile phase for potential impurities and API on diode-array detector were constructed. Optimal chromatography separation conditions for impurities and API were proposed. The UV spectra of API and impurities were presented. The API peak purity by mass spectrometric detector was determined. Method of the quantitative determination of the API in 1 % solution for injection was elaborated. Total sample preparation uncertainty was predicted. Method was validated according to European and Ukrainian Pharmacopeia. It was applied for real samples solutions for injection.

Conclusions. The chromatography separation conditions of impurities and piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetate were studied The method of determination of piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetate in 1 % solution for injection was elaborated.

The results of the method validation show that it is specific and meet the requirements of linearity, precision and accuracy. 

References

Parchenko, V. V., Panasenko, O. I., Knysh, E. G., Vasiuk, S. O., & Tarkhanova, O. O. (2009). Yakisne ta kilkisne vyznachennia piperydynii 2-[5-(furan-2-il)-4-fenil-1, 2, 4-tryazol-3-iltio] atsetatu 1% ta 2,5% rozchynakh [Qualitative and quantitative determination of the Piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetate 1% and 2,5% solutions]. Zaporozhye medical journal, 3, 111–112. [in Ukrainian].

Parchenko, V. V., Panasenko, O. I., Knysh, E. G., Vasyuk S. O., & Tarkhanova, O. O. (2009). Rozrobka metodyky kilkisnoho vyznachennia piperydyniiu 2-[5-(furan-2-il)-4-fenil-1,2,4- tryazol-3-iltio] atsetatu v substantsii [Working out of methods quantitative determination piperidiniy 2-[5-(furan-2-il)-4-phenil-1,2,4-triazol-3-ilthio]acetate in the substance]. Ukrainskyi biofarmatsevtychnyi zhurnal, 4, 44–45. [in Ukrainian].

(2008) Derzhavna Farmakopeia Ukrainy. Dopovnennia 2. [The State Pharmacopoeia of Ukraine. Supplement 2]. Kharkiv: RІREH. [in Ukrainian].

Parchenko, V.V. (2006). Syntez, fizyko-khimichni ta biolohichni vlastyvosti pokhidnykh 1,2,4-triazol-3-tionu, yaki mistyat' yadro furanu (Dis… kand. farm. nauk). [Synthesis, physicochemical and biological properties of derivatives of 1,2,4-triazoles-3-thione containing core furan. Dr. farm. sci. diss.]. Zaporizhzhia [in Ukrainian].

Varynskyj, B. O. (2015) Doslidzhennia kharkterystyk utrymuvannia riadu hidrazydiv karbonovykh kyslot i hidrazynokabotioamidiv, vykhidnykh rechovyn pry syntezi substantsii dlia vyhotovlennia likarskykh zasobiv metodom VERKh-UF-ESI-MS [Study retention characteristics of series hydrazides of carboxylic acids and hydrazynocabothioamids, starting materials in the synthesis of bulk drugs for manufacturing of the pharmaceutical preparations by HPLC-UV-ESI-MS]. Problemy viiskovoi okhorony zdorovia. Zbirnyk naukovykh prats Ukrainskoi viiskovo-medychnoi akademii, 43, 320–330. [in Ukrainian].

Varynskyi, B. O., Knysh, Ye. G., Parchenko, V. V., Pаnаsenkо, O. І. & Kаplаushenkо, A. G. (2015) Vyvchennia zakonomirnostei utrymuvannia potentsiinykh likarskykh substantsii riadu 1,2,4-triazol-3-iltioatsetatnykh kyslot ta yikh solei metodom VERKh / DMD-MS [The study of retention regularities for the potential drug substances of 1,2,4-triazol-3-ylthioacetic acids and their salts series by the method of HPLC/DAD-MS]. Zhurnal orhanichnoi ta farmatsevtychnoi khimii, 4, 68–72. [in Ukrainian].

Varynskyi, B. O. (2016) Vyvchennia metodom VERKh-DMD-MS zakonomirnostei utrymuvannia riadu 1,2,4-triazol-3-tioniv – napivproduktiv v syntezi aktyvnykh farmatsevtychnykh inhrediientiv [Study by HPLC-DAD-MS retention regularities of the 1,2,4-triazoles-3-tione series – intermediate materials in the synthesis of active pharmaceutical ingredients for medicine manufacture]. Farmakom, 1, 32–40. [in Ukrainian].

(2001) Derzhavna Farmakopeia Ukrainy [The State Pharmacopoeia of Ukraine]. Kharkiv: RІREH. [in Ukrainian].

(2013). European Pharmacopoeia. Strasbourg, France: Council of Europe.

(2004). Derzhavna Farmakopeia Ukrainy. Dopovnennia 1. [The State Pharmacopoeia of Ukraine. Supplement 1]. Kharkiv: RІREH. [in Ukrainian].

Grizodub, A. I. (2011) Standartizovannye procedury validacii metodik kontrolya kachestva lekarstvennykh sredstv [Standardized validation procedures for method of medicines quality control]. Analiticheskaya khimiya v sozdanii, standartizacii y kontrole kachestva lekarstvennykh sredstv, V. P. Georgievskogo (Ed.), (Vol. 3). Kharkiv, pp. 934–1063. [in Russian].

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How to Cite

1.
Varynskyi BO, Parchenko VV, Kaplaushenko АG. Development and validation of HPLC-DAD method of determination piperidinium 2-((5-(furan-2-yl)-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetate in 1 % solution. Zaporozhye Medical Journal [Internet]. 2017Nov.15 [cited 2024Dec.28];(6). Available from: http://zmj.zsmu.edu.ua/article/view/115313

Issue

No. 6 (2017)

Section

Problems of pharmacy

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