AQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS.

Mycophenolic Acid Chromatography, High Pressure Liquid / methods Drug Contamination / prevention & control Limit of Detection Reproducibility of Results

Journal

Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288

Informations de publication

Date de publication:
09 11 2022
Historique:
received: 22 07 2022
accepted: 21 10 2022
entrez: 9 11 2022
pubmed: 10 11 2022
medline: 15 11 2022
Statut: epublish

Résumé

We report an ideal method for quantifying impurities in mycophenolate mofetil drug substances and their oral suspension preparations. We developed a systematic and eco-friendly analytical approach utilizing quality by design (QbD) and green chemistry principles. Initially, the critical method parameters (CMPs) were screened using a D-optimal design. The robust final method conditions were optimized using a systematic central composite design (CCD). Through graphical and numerical optimization, the protocol conditions were augmented. The pH of mobile phase buffer (25 mM KH

Identifiants

DOI: 10.1038/s41598-022-22998-0 PMID: 36352016 PMC: PMC9646803
pubmed: 36352016
doi: 10.1038/s41598-022-22998-0
pii: 10.1038/s41598-022-22998-0
pmc: PMC9646803
doi:

Substances chimiques

Mycophenolic Acid HU9DX48N0T

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

19138

Informations de copyright

© 2022. The Author(s).

Références

Biomed Chromatogr. 2022 Jun;36(6):e5359
pubmed: 35203103
Talanta. 2022 Feb 1;238(Pt 2):123046
pubmed: 34801903
J Chromatogr Sci. 2009 Feb;47(2):149-55
pubmed: 19222923
J AOAC Int. 2022 Sep 6;105(5):1247-1257
pubmed: 35686891
J Chromatogr B Biomed Appl. 1994 Apr 1;654(2):249-56
pubmed: 8044285
Anal Chem. 2001 Jan 1;73(1):41-6
pubmed: 11195509
Biomed Chromatogr. 2021 Jul;35(7):e5096
pubmed: 33605444
J Pharm Biomed Anal. 2011 Sep 10;56(2):423-8
pubmed: 21676571
Talanta. 2018 May 1;181:204-209
pubmed: 29426502
Biomed Chromatogr. 2000 Oct;14(6):373-83
pubmed: 11002275
Anal Chem. 2020 Jul 21;92(14):10076-10082
pubmed: 32538619
J Pharm Anal. 2014 Jun;4(3):205-216
pubmed: 29403884
J Chromatogr B Biomed Sci Appl. 2001 May 5;755(1-2):355-9
pubmed: 11393725
Anal Chem. 2019 Feb 19;91(4):2577-2585
pubmed: 30624912
J Pharm Biomed Anal. 2016 Nov 30;131:400-409
pubmed: 27643862
J Chromatogr B Biomed Appl. 1996 Jun 7;681(2):347-53
pubmed: 8811446
Molecules. 2021 Nov 29;26(23):
pubmed: 34885834
J Pharm Anal. 2018 Apr;8(2):86-95
pubmed: 29736294
J Pharm Biomed Anal. 2013 May 5;78-79:65-74
pubmed: 23454599
Anal Methods. 2021 Sep 7;13(33):3705-3723
pubmed: 34338254
RSC Adv. 2021 Sep 7;11(45):27820-27831
pubmed: 35480770
Pharm Methods. 2012 Jul;3(2):90-3
pubmed: 23781485
Clin Chem. 1999 Mar;45(3):419-22
pubmed: 10053049
Biomed Chromatogr. 2021 Nov;35(11):e5194
pubmed: 34110035
J Sep Sci. 2022 May;45(10):1711-1726
pubmed: 35279949
Arch Pharm Res. 2011 Jan;34(1):59-69
pubmed: 21468916
J Pharm Biomed Anal. 2018 Nov 30;161:110-121
pubmed: 30145448
J Chromatogr A. 2022 Aug 30;1679:463380
pubmed: 35970050
J Pharm Biomed Anal. 2006 Mar 18;40(5):1268-72
pubmed: 16253464
J Pharm Biomed Anal. 2021 Jul 15;201:114091
pubmed: 33964725
Chem Soc Rev. 2010 Jan;39(1):301-12
pubmed: 20023854
J Anal Methods Chem. 2012;2012:875942
pubmed: 22567572

Auteurs

Siva Krishna Muchakayala (SK)

Douglas Pharma US Inc, 1035 Louis Drive, Warminster, PA, 18974, USA.
Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Telangana, 502329, India.

Naresh Kumar Katari (NK)

Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Telangana, 502329, India. nkatari@gitam.edu.
School of Chemistry & Physics, College of Agriculture, Engineering & Science, Westville Campus, University of KwaZulu-Natal, P Bag X 54001, Durban, 4000, South Africa. nkatari@gitam.edu.

Kalyan Kumar Saripella (KK)

Douglas Pharma US Inc, 1035 Louis Drive, Warminster, PA, 18974, USA.

Henele Schaaf (H)

Douglas Pharma US Inc, 1035 Louis Drive, Warminster, PA, 18974, USA.

Vishnu Murthy Marisetti (VM)

Analytical Research and Development, ScieGen Pharmaceuticals Inc, 89 Arkay Drive, Hauppauge, NY, 11788, USA.

Leela Prasad Kowtharapu (LP)

Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Telangana, 502329, India.

Sreekantha Babu Jonnalagadda (SB)

School of Chemistry & Physics, College of Agriculture, Engineering & Science, Westville Campus, University of KwaZulu-Natal, P Bag X 54001, Durban, 4000, South Africa. Jonnalagaddas@ukzn.ac.za.

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Classifications MeSH

questionsmedicales.fr › Lipides › Acides gras › Acide mycophénolique › AQbD based green UPLC method to determine...
questionsmedicales.fr › Techniques d'investigation › Techniques de chimie analytique › Chromatographie › Chromatographie en phase liquide › Chromatographie en phase liquide à haute performance › AQbD based green UPLC method to determine...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Contamination de médicament › AQbD based green UPLC method to determine...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Sensibilité et spécificité › Limite de détection › AQbD based green UPLC method to determine...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Reproductibilité des résultats › AQbD based green UPLC method to determine...