Development of control procedures of related impurities in 7-(4-fluoro-benzyl)-3-tioxo-2,3-dihydro[1,2,4]triazolo[4,3-а]pyrazin-8(7Н)-one substance

Кристина Юрьевна Нетёсова,Светлана Николаевна Губарь,Ирина Александровна Журавель

doi:10.15587/2313-8416.2016.61864

Кристина Юрьевна Нетёсова, Светлана Николаевна Губарь + Show 1 more

Open Access

https://doi.org/10.15587/2313-8416.2016.61864

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Journal: ScienceRise	Publication Date: Mar 15, 2016
License type: cc-by

Abstract

Purity control of pharmaceutical substances is an essential part of the modern requirements for substances on the stage of pharmaceutical development. Aim. The aim of research was to develop and validate the procedure for determination of related impurities in the new substance of 7-(4-fluoro-benzyl)-3-tioxo-2,3-dihydro[1,2,4]triazolo[4,3-а]pyrazin-8(7н)-one by the method of high-performance liquid chromatography (HPLC). Methods. HPLC method has been chosen among other methods since this high sensitive and selective analytical method allows monitoring related impurities in the given substance. Results. The method for determination of related impurities in the new substance of 7-(4-fluoro-benzyl)-3-tioxo-2,3-dihydro[1,2,4]triazolo[4,3-а]pyrazin-8(7н)-one has been developed. Validation characteristics have been determined, and their compliance with the relevant eligibility criteria has been experimentally verified. Conclusion. The results of research show that the developed method meets the modern requirements for analytical methods of the content of impurities limit determination and allows clearly characterize the content of impurities in the new API

Highlights

Purity control of pharmaceutical substances is an essential part of the modern requirements for substances
high-performance liquid chromatography (HPLC) method has been chosen among other methods
The results of research show that the developed method meets the modern requirements for analytical methods of the content

Summary

Introduction

Purity control of pharmaceutical substances is an essential part of the modern requirements for substances on the stage of pharmaceutical development. Как объект исследования была выбрана новая субстанция 7-(4-фторбензил)-3-тиоксо-2,3-дигидро[1, 2,4]триазоло[4,3-а]пиразин-8(7Н)-он. В соответствии со схемой синтеза в субстанции 7-(4-фторбензил)-3-тиоксо-2,3-дигидро-[1,2,4]триазоло[4,3-а]пиразин-8(7Н)-она могут присутствовать примеси, которые приведены в табл. Таблица 1 Примеси субстанции 7-(4-фторбензил)-3-тиоксо-2,3-дигидро[1,2,4]-триазоло[4,3-а]пиразин-8(7Н)-она

Results

Conclusion