Green Strategies toward Eco-Friendly HPLC Methods in Pharma Analysis

Abstract

The global need for changing the processes in order to meet the green analytical chemistry (GAC) criteria is a great challenge for the pharmaceutical industry. High-performance liquid chromatography (HPLC), as one of the most frequently used techniques in various stages in the pharmaceutical industry, generates huge amounts of organic toxic waste. Therefore, the implementation of the GAC principles in pharma analysis is highly required. Although the number of published papers concerning green chromatography approaches is constantly increasing, the use of eco-friendly HPLC methods in the pharma industry has not been widely implemented. The reasons for this mainly include the need for adaptation of the conventional HPLC instruments, lack of time, lack of experience, or uncertainty of the analysts regarding fulfillment of the method criteria. In this chapter, an overview of green strategies that can be easily applied to conventional instruments for liquid chromatography (LC) in developing eco-friendly HPLC methods in pharma analysis is given. The aim is to emphasize that the green method development in pharma analysis can be easily accomplished and to encourage the analytical community in the pharmaceutical industry not only to develop but also to transfer the already established conventional HPLC methods into green ones.

Eco-friendly RP-HPLC method for determination of diazepam in coated tablet

“…To achieve this, the first step of the method development was to replace the organic solvents (MeOH and ACN) in the mobile phase of the conventional (referent) USP method with EtOH, an environmentally friendly solvent. 2,3 Considering that the organic solvent content in the reference method was 60 % and EtOH has higher elution strength than ACN and MeOH, the preliminary investigations started with the mobile phase containing 50 % EtOH. Considering that the pKa value for diazepam is 3.4, 5 and the pH value of the mobile phase (H2O: EtOH, 50:50, v/v %) is 6.5, these chromatographic conditions allowed for ionization of the DZP molecule with acceptable retention.…”

“…1 The implementation of the GAC principles in the process of green chromatographic method development, as well as the transfer of the conventional HPLC methods into ecofriendly solutions, is an essential part of the development strategy in the pharmaceutical industry. 2 In particular, GAC principles play a crucial role in the modern industry's development strategy. Reverse phase high-performance liquid chromatography (RP-HPLC) is the most commonly employed technique in pharmaceutical quality control.…”

“…Namely, the chemical waste generated annually by HPLC instruments worldwide is estimated at 34 million liters. 2,3 Benzodiazepines play a crucial role in treating chronic psychiatric disorders, anxiety and insomnia. They have largely replaced other medications used for these indications.…”

Green Analytical Chemistry to Eco-Friendly HPLC Techniques in Pharmaceutical Analysis: A Review

“…GAC principles were recognized by scientists, researchers, and analysts, leading to an increase in papers published in various GAC fields (fundamentals, spectroscopy, electrochemistry, and separation methods) [5]. The pharmaceutical industry is facing a global need to change activities to meet GAC measures, as a study exposed by McMaster University in 2019 showed that it emits more greenhouse gases than the automotive production sector [6]. The pharmaceutical industry places various emphases on pharma analysis, and HPLC is one of the most often utilized methods.…”

“…Green Analytical Chemistry (GAC) is an effort to find workable solutions to off-line waste management in order to replace dirty practices with hygienic ones [6].…”