Abstract

Aim. The development of the pharmaceutical industry of Ukraine and the world has led to an increase in the need for the use of hazardous and toxic chemicals and solvents, which affects the safety of the environment and directly employees of pharmaceutical companies.Therefore, one of the solutions to this problem is the implementation of “green chemistry” approaches in pharmaceutical quality control laboratories.Materials and methods. Chromatographic separation methods are used for the qualitative and quantitative analysis of raw materials and finished dosage forms, the determination of substances that are formed during the degradation of active substances and allow rapid analysis of complex mixtures.Results. For the implementation of principles in the laboratory of pharmaceutical companies, it is necessary to evaluate the possibility of using rapid quality control methods such as gas chromatography, ultra-high performance liquid chromatography, and absorption spectrophotometry in the ultraviolet and visible regions.Conclusions. Approaches to greening of analytical procedures used in quality control of pharmaceuticals have been studied. Ways of implementation of modern approaches of methods of green chemistry to chromatographic methods are offered. On the basis of the developed decision tree the design of development and greening of the methods of quality control of benzidamine dosage forms is proposed

Highlights

  • Global Pharmaceutical industry takes one of the leading places of constant evolvement and expansion

  • There have been described a lot of principles of analytical methods greening based on minimization of solvents utilization, use of fast methods like UV spectrophotometry, simultaneous analysis of several quality parameters with one analytical test that is supposed to be a crucial strategy for «green analytical chemistry», as the outcome may match key principles together with performance sustainability

  • Techniques for «analytical methods greening», which are used in quality control of pharmaceutical products, were studied

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Summary

Introduction

Global Pharmaceutical industry takes one of the leading places of constant evolvement and expansion. Such a huge growth of industry inevitably implies the growing concern of environment problems, which are pollution, wastes treatment, energy consumption and adverse effect on the healthy future of nations [1]. In contemporary pharmaceutical analysis major part play various chromatographic methods [4, 5]. They significantly differ one from another by their ability for separation, and by the influence on the laboratory staff, waste production and resource consumption. If the API manufacturer obliged to use Pharmacopeia methods the requirements for the finished dosage form are less strict and any validated in-house method can be used for quality control

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