In vitro Dissolution Profile at Different Biological pH Conditions of Hydroxychloroquine Sulfate Tablets Is Available for the Treatment of COVID-19.
Identifieur interne : 000415 ( Main/Corpus ); précédent : 000414; suivant : 000416In vitro Dissolution Profile at Different Biological pH Conditions of Hydroxychloroquine Sulfate Tablets Is Available for the Treatment of COVID-19.
Auteurs : Thirupathi Dongala ; Naresh Kumar Katari ; Santhosh Kumar Ettaboina ; Anand Krishnan ; Murtaza M. Tambuwala ; Kamal DuaSource :
- Frontiers in molecular biosciences [ 2296-889X ] ; 2020.
Abstract
Hydroxychloroquine sulfate is one of an extensive series of 4-aminoquinolines with antimalarial activity. Moreover, it is used for the treatment of rheumatoid arthritis. Sometimes, hydroxychloroquine sulfate is beneficial for the treatment of autoimmune diseases. Based on recent clinical experiments, it is exploited for the treatment of COVID-19, coronavirus across the globe. The chromatogram separation was achieved by using Agilent, Zorbax C8, 250 mm × 4.6 mm i.d., column. The buffer consists of 0.01 M of 1-pentane sulfonic acid and 0.02% of orthophosphoric acid in purified water. Mixed buffer, acetonitrile, and methanol (800:100:100 v/v). The flow rate was 1.0 ml min-1, and injection volume was 10 μl. Detection was made at 254 nm by using a dual absorbance detector (DAD). The reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated as per the current International Conference on Harmonization (ICH) guidelines to estimate hydroxychloroquine sulfate tablets. As part of method validation, specificity, linearity, precision, and recovery parameters were verified. The concentration and area relationships were linear (R2 > 0.999) over the concentration range of 25-300 μg ml-1 for hydroxychloroquine (HCQ). The relative standard deviations for precision and intermediate precision were <1.5%. The proposed RP-HPLC generic method was applied successfully to evaluate the in vitro dissolution profile with different pH conditions such as 0.1 N HCl, pH 4.5 acetate buffer, and pH 6.8 phosphate buffers as US-marketed reference products.
DOI: 10.3389/fmolb.2020.613393
PubMed: 33521056
PubMed Central: PMC7841110
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Tambuwala</name><affiliation><nlm:affiliation>School of Pharmacy and Pharmaceutical Science, Ulster University, Coleraine, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Dua, Kamal" sort="Dua, Kamal" uniqKey="Dua K" first="Kamal" last="Dua">Kamal Dua</name><affiliation><nlm:affiliation>Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, NSW, Australia.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Priority Research Centre for Healthy Lungs, Hunter Medical Research Institute (HMRI) & School of Biomedical Sciences and Pharmacy, The University of Newcastle (UoN), Callaghan, NSW, Australia.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Pharmaceutical Sciences, Shoolini University of Biotechnology and Management Sciences, Solan, India.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33521056</idno><idno type="pmid">33521056</idno><idno type="doi">10.3389/fmolb.2020.613393</idno><idno type="pmc">PMC7841110</idno><idno type="wicri:Area/Main/Corpus">000415</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000415</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en"><i>In vitro</i> Dissolution Profile at Different Biological pH Conditions of Hydroxychloroquine Sulfate Tablets Is Available for the Treatment of COVID-19.</title><author><name sortKey="Dongala, Thirupathi" sort="Dongala, Thirupathi" uniqKey="Dongala T" first="Thirupathi" last="Dongala">Thirupathi Dongala</name><affiliation><nlm:affiliation>Aurex Laboratories LLC, East Windsor, NJ, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Chemistry, School of Science GITAM Deemed to be University, Hyderabad, India.</nlm:affiliation></affiliation></author><author><name sortKey="Katari, Naresh Kumar" sort="Katari, Naresh Kumar" uniqKey="Katari N" first="Naresh Kumar" last="Katari">Naresh Kumar Katari</name><affiliation><nlm:affiliation>Department of Chemistry, School of Science GITAM Deemed to be University, Hyderabad, India.</nlm:affiliation></affiliation></author><author><name sortKey="Ettaboina, Santhosh Kumar" sort="Ettaboina, Santhosh Kumar" uniqKey="Ettaboina S" first="Santhosh Kumar" last="Ettaboina">Santhosh Kumar Ettaboina</name><affiliation><nlm:affiliation>Aurex Laboratories LLC, East Windsor, NJ, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Krishnan, Anand" sort="Krishnan, Anand" uniqKey="Krishnan A" first="Anand" last="Krishnan">Anand Krishnan</name><affiliation><nlm:affiliation>Department of Chemical Pathology, Faculty of Health Sciences and National Health Laboratory Service, School of Pathology, University of the Free State, Bloemfontein, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Tambuwala, Murtaza M" sort="Tambuwala, Murtaza M" uniqKey="Tambuwala M" first="Murtaza M" last="Tambuwala">Murtaza M. Tambuwala</name><affiliation><nlm:affiliation>School of Pharmacy and Pharmaceutical Science, Ulster University, Coleraine, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Dua, Kamal" sort="Dua, Kamal" uniqKey="Dua K" first="Kamal" last="Dua">Kamal Dua</name><affiliation><nlm:affiliation>Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, NSW, Australia.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Priority Research Centre for Healthy Lungs, Hunter Medical Research Institute (HMRI) & School of Biomedical Sciences and Pharmacy, The University of Newcastle (UoN), Callaghan, NSW, Australia.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>School of Pharmaceutical Sciences, Shoolini University of Biotechnology and Management Sciences, Solan, India.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Frontiers in molecular biosciences</title><idno type="ISSN">2296-889X</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Hydroxychloroquine sulfate is one of an extensive series of 4-aminoquinolines with antimalarial activity. Moreover, it is used for the treatment of rheumatoid arthritis. Sometimes, hydroxychloroquine sulfate is beneficial for the treatment of autoimmune diseases. Based on recent clinical experiments, it is exploited for the treatment of COVID-19, coronavirus across the globe. The chromatogram separation was achieved by using Agilent, Zorbax C8, 250 mm × 4.6 mm i.d., column. The buffer consists of 0.01 M of 1-pentane sulfonic acid and 0.02% of orthophosphoric acid in purified water. Mixed buffer, acetonitrile, and methanol (800:100:100 v/v). The flow rate was 1.0 ml min<sup>-1</sup>, and injection volume was 10 μl. Detection was made at 254 nm by using a dual absorbance detector (DAD). The reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated as per the current International Conference on Harmonization (ICH) guidelines to estimate hydroxychloroquine sulfate tablets. As part of method validation, specificity, linearity, precision, and recovery parameters were verified. The concentration and area relationships were linear (<i>R</i><sup>2</sup> > 0.999) over the concentration range of 25-300 μg ml<sup>-1</sup> for hydroxychloroquine (HCQ). The relative standard deviations for precision and intermediate precision were <1.5%. The proposed RP-HPLC generic method was applied successfully to evaluate the <i>in vitro</i> dissolution profile with different pH conditions such as 0.1 N HCl, pH 4.5 acetate buffer, and pH 6.8 phosphate buffers as US-marketed reference products.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33521056</PMID><DateRevised><Year>2021</Year><Month>02</Month><Day>02</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">2296-889X</ISSN><JournalIssue CitedMedium="Print"><Volume>7</Volume><PubDate><Year>2020</Year></PubDate></JournalIssue><Title>Frontiers in molecular biosciences</Title><ISOAbbreviation>Front Mol Biosci</ISOAbbreviation></Journal><ArticleTitle><i>In vitro</i> Dissolution Profile at Different Biological pH Conditions of Hydroxychloroquine Sulfate Tablets Is Available for the Treatment of COVID-19.</ArticleTitle><Pagination><MedlinePgn>613393</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3389/fmolb.2020.613393</ELocationID><Abstract><AbstractText>Hydroxychloroquine sulfate is one of an extensive series of 4-aminoquinolines with antimalarial activity. Moreover, it is used for the treatment of rheumatoid arthritis. Sometimes, hydroxychloroquine sulfate is beneficial for the treatment of autoimmune diseases. Based on recent clinical experiments, it is exploited for the treatment of COVID-19, coronavirus across the globe. The chromatogram separation was achieved by using Agilent, Zorbax C8, 250 mm × 4.6 mm i.d., column. The buffer consists of 0.01 M of 1-pentane sulfonic acid and 0.02% of orthophosphoric acid in purified water. Mixed buffer, acetonitrile, and methanol (800:100:100 v/v). The flow rate was 1.0 ml min<sup>-1</sup>, and injection volume was 10 μl. Detection was made at 254 nm by using a dual absorbance detector (DAD). The reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated as per the current International Conference on Harmonization (ICH) guidelines to estimate hydroxychloroquine sulfate tablets. As part of method validation, specificity, linearity, precision, and recovery parameters were verified. The concentration and area relationships were linear (<i>R</i><sup>2</sup> > 0.999) over the concentration range of 25-300 μg ml<sup>-1</sup> for hydroxychloroquine (HCQ). The relative standard deviations for precision and intermediate precision were <1.5%. The proposed RP-HPLC generic method was applied successfully to evaluate the <i>in vitro</i> dissolution profile with different pH conditions such as 0.1 N HCl, pH 4.5 acetate buffer, and pH 6.8 phosphate buffers as US-marketed reference products.</AbstractText><CopyrightInformation>Copyright © 2021 Dongala, Katari, Ettaboina, Krishnan, Tambuwala and Dua.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Dongala</LastName><ForeName>Thirupathi</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Aurex Laboratories LLC, East Windsor, NJ, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Chemistry, School of Science GITAM Deemed to be University, Hyderabad, India.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Katari</LastName><ForeName>Naresh Kumar</ForeName><Initials>NK</Initials><AffiliationInfo><Affiliation>Department of Chemistry, School of Science GITAM Deemed to be University, Hyderabad, India.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ettaboina</LastName><ForeName>Santhosh Kumar</ForeName><Initials>SK</Initials><AffiliationInfo><Affiliation>Aurex Laboratories LLC, East Windsor, NJ, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Krishnan</LastName><ForeName>Anand</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Chemical Pathology, Faculty of Health Sciences and National Health Laboratory Service, School of Pathology, University of the Free State, Bloemfontein, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tambuwala</LastName><ForeName>Murtaza M</ForeName><Initials>MM</Initials><AffiliationInfo><Affiliation>School of Pharmacy and Pharmaceutical Science, Ulster University, Coleraine, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dua</LastName><ForeName>Kamal</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, NSW, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Priority Research Centre for Healthy Lungs, Hunter Medical Research Institute (HMRI) & School of Biomedical Sciences and Pharmacy, The University of Newcastle (UoN), Callaghan, NSW, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Pharmaceutical Sciences, Shoolini University of Biotechnology and Management Sciences, Solan, India.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>01</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>Switzerland</Country><MedlineTA>Front Mol Biosci</MedlineTA><NlmUniqueID>101653173</NlmUniqueID><ISSNLinking>2296-889X</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">coronavirus disease 2019</Keyword><Keyword MajorTopicYN="N">dissolution</Keyword><Keyword MajorTopicYN="N">hydroxychloroquine sulfate</Keyword><Keyword MajorTopicYN="N">pH</Keyword><Keyword MajorTopicYN="N">validation</Keyword></KeywordList><CoiStatement>TD and SE were employed by the company Aurex Laboratories LLC, 10 lake drive, East Windsor, NJ, USA 08512. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>10</Month><Day>02</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>11</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>2</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>2</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>2</Month><Day>2</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33521056</ArticleId><ArticleId IdType="doi">10.3389/fmolb.2020.613393</ArticleId><ArticleId IdType="pmc">PMC7841110</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>J Pharm Biomed Anal. 2009 May 1;49(4):873-9</Citation><ArticleIdList><ArticleId IdType="pubmed">19201565</ArticleId></ArticleIdList></Reference><Reference><Citation>Cell Res. 2020 Mar;30(3):269-271</Citation><ArticleIdList><ArticleId IdType="pubmed">32020029</ArticleId></ArticleIdList></Reference><Reference><Citation>J Chromatogr. 1985 Mar 22;338(2):422-7</Citation><ArticleIdList><ArticleId IdType="pubmed">3873466</ArticleId></ArticleIdList></Reference><Reference><Citation>J Chromatogr B Analyt Technol Biomed Life Sci. 2007 May 1;850(1-2):481-7</Citation><ArticleIdList><ArticleId IdType="pubmed">17227720</ArticleId></ArticleIdList></Reference><Reference><Citation>J Chromatogr B Biomed Appl. 1995 Apr 21;666(2):347-53</Citation><ArticleIdList><ArticleId IdType="pubmed">7633613</ArticleId></ArticleIdList></Reference><Reference><Citation>J Chromatogr. 1992 Oct 2;581(1):83-92</Citation><ArticleIdList><ArticleId IdType="pubmed">1430010</ArticleId></ArticleIdList></Reference><Reference><Citation>Int J Antimicrob Agents. 2020 Apr;55(4):105932</Citation><ArticleIdList><ArticleId IdType="pubmed">32145363</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Chim Acta. 2013 Jun 5;421:79-84</Citation><ArticleIdList><ArticleId IdType="pubmed">23485647</ArticleId></ArticleIdList></Reference><Reference><Citation>J Chromatogr. 1986 Apr 25;377:454-9</Citation><ArticleIdList><ArticleId IdType="pubmed">3711242</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Infect Dis. 2020 Jul 28;71(15):732-739</Citation><ArticleIdList><ArticleId IdType="pubmed">32150618</ArticleId></ArticleIdList></Reference><Reference><Citation>J Pharm Biomed Anal. 2012 Mar 5;61:86-92</Citation><ArticleIdList><ArticleId IdType="pubmed">22197155</ArticleId></ArticleIdList></Reference><Reference><Citation>Biosci Trends. 2020 Mar 16;14(1):72-73</Citation><ArticleIdList><ArticleId IdType="pubmed">32074550</ArticleId></ArticleIdList></Reference><Reference><Citation>J Pharm Biomed Anal. 2014 Jul;95:200-6</Citation><ArticleIdList><ArticleId IdType="pubmed">24682018</ArticleId></ArticleIdList></Reference><Reference><Citation>J Anal Toxicol. 1994 Sep;18(5):255-60</Citation><ArticleIdList><ArticleId IdType="pubmed">7990442</ArticleId></ArticleIdList></Reference><Reference><Citation>J Pharm Biomed Anal. 2003 Jun 1;32(2):269-75</Citation><ArticleIdList><ArticleId IdType="pubmed">12763536</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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