Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological Fluids

Paracetamol is one of the most widely consumed analgesic and antipyretic medications worldwide. It is frequently analyzed in many quality control (QC) laboratories in pharmaceutical companies, either in raw materials or drug products. It was reported that paracetamol self-toxicity often occurs, lead...

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Main Authors: Ibrahim A. Naguib, Meral Majed, Maram Albogami, Maram Alshehri, Aseel Bukhari, Hadeel Alshabani, Izzeddin Alsalahat, Heba-Alla H. Abd-ElSalam
Format: Article
Language:English
Published: MDPI AG 2023-04-01
Series:Separations
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Online Access:https://www.mdpi.com/2297-8739/10/5/283
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author Ibrahim A. Naguib
Meral Majed
Maram Albogami
Maram Alshehri
Aseel Bukhari
Hadeel Alshabani
Izzeddin Alsalahat
Heba-Alla H. Abd-ElSalam
author_facet Ibrahim A. Naguib
Meral Majed
Maram Albogami
Maram Alshehri
Aseel Bukhari
Hadeel Alshabani
Izzeddin Alsalahat
Heba-Alla H. Abd-ElSalam
author_sort Ibrahim A. Naguib
collection DOAJ
description Paracetamol is one of the most widely consumed analgesic and antipyretic medications worldwide. It is frequently analyzed in many quality control (QC) laboratories in pharmaceutical companies, either in raw materials or drug products. It was reported that paracetamol self-toxicity often occurs, leading to the frequent analysis of paracetamol in toxicological centers in biological fluids. Green analytical chemistry (GAC) is growing to be a global philosophy; therefore, the high frequency of paracetamol analysis poses potential concerns. Chromatographic analytical methods used for the daily analysis of paracetamol could be a potential risk to the environment or the health of the analysts if not thoroughly considered. The presented study aims to establish greenness assessments of nine HPLC methods used to assay paracetamol in raw materials and drug products and twenty-one HPLC methods. The reason for selecting HPLC methods of analysis to be the core of the study is the known reproducibility, reliability and availability in most QC laboratories. The most commonly used metric systems for greenness evaluation are the Analytical GREEnness (AGREE), the eco-scale assessment (ESA) and the national environmental methods index (NEMI) which have been used in this comparative study. The greenest chromatographic method for the analysis of paracetamol in raw materials and drug products was introduced by Rao et al. (the obtained scores were ESA = 76 and AGREE = 0.62, while the greenest chromatographic method for the analysis of paracetamol in biological fluids was proposed by Modick et al.). The obtained scores were ESA = 85 and AGREE = 0.7. The NEMI tool proved to have limited performance compared to other metric systems, hence it could not be used alone. Accordingly, the collaboration of NEMI results with ESA and AGREE for greenness assessment is highly recommended to reach appropriate conclusions.
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spelling doaj.art-86f5c05c56f54893a4410bb4622209542023-11-18T03:15:52ZengMDPI AGSeparations2297-87392023-04-0110528310.3390/separations10050283Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological FluidsIbrahim A. Naguib0Meral Majed1Maram Albogami2Maram Alshehri3Aseel Bukhari4Hadeel Alshabani5Izzeddin Alsalahat6Heba-Alla H. Abd-ElSalam7Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaCollege of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaCollege of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaCollege of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaCollege of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaCollege of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaUK Dementia Research Institute Cardiff, School of Medicine, Cardiff University, Cardiff CF24 1TP, UKPharmaceutical Chemistry Department, Faculty of Pharmacy & Drug Technology, Egyptian Chinese University, Cairo 11786, EgyptParacetamol is one of the most widely consumed analgesic and antipyretic medications worldwide. It is frequently analyzed in many quality control (QC) laboratories in pharmaceutical companies, either in raw materials or drug products. It was reported that paracetamol self-toxicity often occurs, leading to the frequent analysis of paracetamol in toxicological centers in biological fluids. Green analytical chemistry (GAC) is growing to be a global philosophy; therefore, the high frequency of paracetamol analysis poses potential concerns. Chromatographic analytical methods used for the daily analysis of paracetamol could be a potential risk to the environment or the health of the analysts if not thoroughly considered. The presented study aims to establish greenness assessments of nine HPLC methods used to assay paracetamol in raw materials and drug products and twenty-one HPLC methods. The reason for selecting HPLC methods of analysis to be the core of the study is the known reproducibility, reliability and availability in most QC laboratories. The most commonly used metric systems for greenness evaluation are the Analytical GREEnness (AGREE), the eco-scale assessment (ESA) and the national environmental methods index (NEMI) which have been used in this comparative study. The greenest chromatographic method for the analysis of paracetamol in raw materials and drug products was introduced by Rao et al. (the obtained scores were ESA = 76 and AGREE = 0.62, while the greenest chromatographic method for the analysis of paracetamol in biological fluids was proposed by Modick et al.). The obtained scores were ESA = 85 and AGREE = 0.7. The NEMI tool proved to have limited performance compared to other metric systems, hence it could not be used alone. Accordingly, the collaboration of NEMI results with ESA and AGREE for greenness assessment is highly recommended to reach appropriate conclusions.https://www.mdpi.com/2297-8739/10/5/283AGREEbiological fluidsESAGAGHPLCNEMI
spellingShingle Ibrahim A. Naguib
Meral Majed
Maram Albogami
Maram Alshehri
Aseel Bukhari
Hadeel Alshabani
Izzeddin Alsalahat
Heba-Alla H. Abd-ElSalam
Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological Fluids
Separations
AGREE
biological fluids
ESA
GAG
HPLC
NEMI
title Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological Fluids
title_full Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological Fluids
title_fullStr Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological Fluids
title_full_unstemmed Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological Fluids
title_short Greenness Assessment of HPLC Analytical Methods with Common Detectors for Assay of Paracetamol and Related Materials in Drug Products and Biological Fluids
title_sort greenness assessment of hplc analytical methods with common detectors for assay of paracetamol and related materials in drug products and biological fluids
topic AGREE
biological fluids
ESA
GAG
HPLC
NEMI
url https://www.mdpi.com/2297-8739/10/5/283
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