Table 1 - uploaded by Seema Saroj
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Objective: A state of the art, robust and environmentally benign stability indicating assay method (SIAM) has been developed for model drug Lenalidomide (LEN). Methods: A Green metrics assessment was conducted by environment assessment tool (EAT), analytical method volume intensity (AMVI) and Ecosolvent ® tool. Successful chromatographic separation...
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Context 1
... results obtained after extensive trials taken using different buffers and organic modifier favoured a combination of ammonium acetate buffer having a pH of 5 and MeOH as mobile phase composition which satisfied all criteria viz., optimum retention time which could separate the DPs with higher resolution having least tailing factor and higher number of theoretical plates. This method showed retention time of 7.91 min with a theoretical plate of 6672 having asymmetry of 0.98 as displayed in following Figure 2 and summarized in Table 1. ...
Citations
From the pharmaceutical industry is known the approach Quality-by-Design (QbD) and this has great influence on analytical methods and procedures it employs. There is even proposed “analytical quality-by-design” to emphasise the role of analytical chemistry in quality control system of this industry.
However, every branch of chemical industry in principle has the quality system where big part is related to chemical analysis and respective quality control system. By time more green chemistry principles like minimising the generation of waste and reducing the use of materials and energy as well as including analytical measurements in large-scale quality-control processes, are integrated into production of chemicals. The integration of green chemistry principles in analytical chemistry will bring these principles also into QbD of particular industry. In present work the review of examples is given on introduction of green analytical methods into QbD.
This article reviews the various analytical methods reported so far in the literature for the determination of stability and impurity profile the lenalidomide and palbociclib anti cancer drugs in single or combination with other drugs in bulk, pharmaceutical dosage forms, biological fluids, stability indicating and impurity profiling methods. The analytical methods used for the estimation of lenalidomide and palbociclib anticancer drugs reviewed in this paper includes ultraviolet spectrophotometry,high performance liquid chromatography (HPLC) ,ultra performance liquid chromatography (UPLC) ,liquid chromatography-mass spectrometry (LC-MS) and electrophoresis. This review focus on the effect of all chromatographic parameters so as to provide as fast, reliable and cost effective methodology of testing. Method development is the process of proving that analytical method is acceptable for use to measure the concentration of active pharmaceutical ingredient in a specific compound dosage form which must be validated to provide reliable data for regulatory submissions. This reviewed is mainly on analytical method development and validation, stability indicating methods, simultaneous estimation methods and bioanalytical methods. The review covers the time period from 2007 to 2019 during which analytical methods including all types of spectrophotometric and chromatographic techniques were reported. The Review covers lenalidomide and palbociclib API and formulation analytical and bioanalytical methods.
The chemical and analytical research merely raised serious concern about the ecological effects of their practices, particularly the use and generation of toxic reagents/solvents. The greenness assessment of analytical methods gains more consideration to estimate pharmaceuticals with minimal environmental hazardous substances. The assessment of greenness is essential to evaluate their credibility to make sustainable methods. The goal is to explore innovative substitutes to replace polluting analytical methods with eco-friendly ones. However, evaluating such greener liquid chromatographic (LC) methods with suitable systematic evaluation tools has not yet been widely adopted. The goal is to explore innovative substitutes to replace polluting analytical methods with eco-friendly ones. This scoping review aimed to identify and review the available methods to evaluate the green-ness profile. The quest plan comprised an analysis of PubMed, Scopus, ScienceDirect, and Google that narrowed down 49 articles that described green LC methods from 2010 onwards. Most articles that claimed greener LC methods were not substantially evaluated by suitable tools. The green metric tools used, such as National Environmental Method Index (NEMI), modified NEMI, and Green Analytical Procedure Index (GAPI) analytical eco-scale and AGREE, have been examined. The raised concern over the importance of understanding the use of assessment tools to minimizes the generation of toxic environmental harmful analytical hazardous waste and control unsustainable practices, which are the stepping stone for future generations.
