Quantification of grapiprant and its stability testing under changing environmental conditions

2022
journal article
article
5
dc.abstract.enGrapiprant is a new analgesic and anti-inflammatory drug belonging to the piprant class, approved in 2016 by the FDA Veterinary Medicine Center for the treatment of pain and inflammation associated with osteoarthritis in dogs. It acts as a highly selective antagonist of the EP4 receptor, one of the four prostaglandin E2 (PGE2) receptor subtypes. It has been shown to have anti-inflammatory effects in rat models of acute and chronic inflammation and clinical studies in people with osteoarthritis. The current state of knowledge suggests the possibility of using it in oncological therapy. The manuscript presents the development of conditions for the identification and quantitative determination of grapiprant by thin-layer chromatography with densitometric detection. The optimal separation of the substance occurs using silica gel 60F$_{254}$ chromatographic plates and the mobile phase containing ethyl acetate-toluene-butylamine. Validation (according to ICH requirements) showed that the developed method is characterized by straightness of results in a wide concentration range with the limit of detection of 146.65 µg/mL. The %RSD values of the precision and accuracy confirm the sensitivity and reliability of the developed procedure. Next, the method was used for quantification of grapiprant in a pharmaceutical preparation, and for stability studies under various environmental conditions. Additionally, the mass studies were carried out on the stressed samples using the UPLC-MS/MS method. The degradation products were primarily characterized by comparing their mass fragmentation profiles with those of the drug. The results indicated a potential degradation pathway for grapiprant.
dc.affiliationSzkoła Doktorska Nauk Medycznych i Nauk o Zdrowiupl
dc.affiliationWydział Farmaceutyczny : Zakład Chemii Organicznejpl
dc.affiliationWydział Farmaceutyczny : Zakład Chemii Nieorganicznejpl
dc.cm.date2022-11-09T23:22:54Z
dc.cm.id110261pl
dc.cm.idOmegaUJCMe69475b901504746877df6c21439d9c3pl
dc.contributor.authorGumułka, Paweł - 233908 pl
dc.contributor.authorTarsa, Monika - 133652 pl
dc.contributor.authorDąbrowska, Monika - 129159 pl
dc.contributor.authorStarek, Małgorzata - 133481 pl
dc.date.accession2022-11-09pl
dc.date.accessioned2022-11-09T23:22:54Z
dc.date.available2022-11-09T23:22:54Z
dc.date.issued2022pl
dc.date.openaccess0
dc.description.accesstimew momencie opublikowania
dc.description.number11pl
dc.description.versionostateczna wersja wydawcy
dc.description.volume10pl
dc.identifier.articleid2821pl
dc.identifier.doi10.3390/biomedicines10112821pl
dc.identifier.eissn2227-9059pl
dc.identifier.issn2227-9059pl
dc.identifier.urihttps://ruj.uj.edu.pl/xmlui/handle/item/303550
dc.identifier.weblinkhttps://www.mdpi.com/2227-9059/10/11/2821pl
dc.languageengpl
dc.pbn.affiliationDziedzina nauk medycznych i nauk o zdrowiu : nauki farmaceutyczne
dc.rightsUdzielam licencji. Uznanie autorstwa 4.0 Międzynarodowa
dc.rights.licenceCC-BY
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/legalcode.pl
dc.share.typeOtwarte czasopismo
dc.subject.engrapiprant
dc.subject.enveterinary drugs
dc.subject.endrug quality
dc.subject.enosteoarthritis
dc.subtypeArticlepl
dc.titleQuantification of grapiprant and its stability testing under changing environmental conditionspl
dc.title.journalBiomedicinespl
dc.typeJournalArticlepl
dspace.entity.typePublication
dc.abstract.en
Grapiprant is a new analgesic and anti-inflammatory drug belonging to the piprant class, approved in 2016 by the FDA Veterinary Medicine Center for the treatment of pain and inflammation associated with osteoarthritis in dogs. It acts as a highly selective antagonist of the EP4 receptor, one of the four prostaglandin E2 (PGE2) receptor subtypes. It has been shown to have anti-inflammatory effects in rat models of acute and chronic inflammation and clinical studies in people with osteoarthritis. The current state of knowledge suggests the possibility of using it in oncological therapy. The manuscript presents the development of conditions for the identification and quantitative determination of grapiprant by thin-layer chromatography with densitometric detection. The optimal separation of the substance occurs using silica gel 60F$_{254}$ chromatographic plates and the mobile phase containing ethyl acetate-toluene-butylamine. Validation (according to ICH requirements) showed that the developed method is characterized by straightness of results in a wide concentration range with the limit of detection of 146.65 µg/mL. The %RSD values of the precision and accuracy confirm the sensitivity and reliability of the developed procedure. Next, the method was used for quantification of grapiprant in a pharmaceutical preparation, and for stability studies under various environmental conditions. Additionally, the mass studies were carried out on the stressed samples using the UPLC-MS/MS method. The degradation products were primarily characterized by comparing their mass fragmentation profiles with those of the drug. The results indicated a potential degradation pathway for grapiprant.
dc.affiliationpl
Szkoła Doktorska Nauk Medycznych i Nauk o Zdrowiu
dc.affiliationpl
Wydział Farmaceutyczny : Zakład Chemii Organicznej
dc.affiliationpl
Wydział Farmaceutyczny : Zakład Chemii Nieorganicznej
dc.cm.date
2022-11-09T23:22:54Z
dc.cm.idpl
110261
dc.cm.idOmegapl
UJCMe69475b901504746877df6c21439d9c3
dc.contributor.authorpl
Gumułka, Paweł - 233908
dc.contributor.authorpl
Tarsa, Monika - 133652
dc.contributor.authorpl
Dąbrowska, Monika - 129159
dc.contributor.authorpl
Starek, Małgorzata - 133481
dc.date.accessionpl
2022-11-09
dc.date.accessioned
2022-11-09T23:22:54Z
dc.date.available
2022-11-09T23:22:54Z
dc.date.issuedpl
2022
dc.date.openaccess
0
dc.description.accesstime
w momencie opublikowania
dc.description.numberpl
11
dc.description.version
ostateczna wersja wydawcy
dc.description.volumepl
10
dc.identifier.articleidpl
2821
dc.identifier.doipl
10.3390/biomedicines10112821
dc.identifier.eissnpl
2227-9059
dc.identifier.issnpl
2227-9059
dc.identifier.uri
https://ruj.uj.edu.pl/xmlui/handle/item/303550
dc.identifier.weblinkpl
https://www.mdpi.com/2227-9059/10/11/2821
dc.languagepl
eng
dc.pbn.affiliation
Dziedzina nauk medycznych i nauk o zdrowiu : nauki farmaceutyczne
dc.rights
Udzielam licencji. Uznanie autorstwa 4.0 Międzynarodowa
dc.rights.licence
CC-BY
dc.rights.uri
http://creativecommons.org/licenses/by/4.0/legalcode.pl
dc.share.type
Otwarte czasopismo
dc.subject.en
grapiprant
dc.subject.en
veterinary drugs
dc.subject.en
drug quality
dc.subject.en
osteoarthritis
dc.subtypepl
Article
dc.titlepl
Quantification of grapiprant and its stability testing under changing environmental conditions
dc.title.journalpl
Biomedicines
dc.typepl
JournalArticle
dspace.entity.type
Publication
Affiliations

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