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Development and validation of a HPLC method for simultaneous determination of Dapivirine and DS003 in combination Microbicide tablet

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dc.contributor.authorGupta, J.
dc.contributor.authorOthman, A.
dc.contributor.authorTao, J.Q.
dc.contributor.authorGarg, S.
dc.date.issued2011
dc.description.abstractA reverse phase liquid chromatographic analytical method was developed for the simultaneous determination of Dapivirine and DS003 content in tablet dosage form. The chromatographic separation was achieved by using a C18 column with mobile phase containing a gradient mixture of 0.05% v/v trifluoroacetic acid in water as mobile phase A and acetonitrile as mobile phase B at a flow rate of 0.5 ml/min. Both of the analytes were quantified with a UV detector at 245 nm. Dapivirine and DS003 were subjected to the stress conditions of oxidation, acid and base hydrolysis and thermolysis. The analytes were found to be stable under acidic and thermal conditions. Dapivirine was not significantly affected by base hydrolysis but was severely affected by oxidative conditions. DS003 was significantly affected by both oxidation and base hydrolysis. The stability-indicating capability of this method was demonstrated by adequate separation of the degradation peaks from those of the actives in the stress degraded samples. The method was validated for linearity, specificity, system suitability, precision and accuracy in accordance with ICH guidelines. The proposed method was applied to quantitate Dapivirine and DS003 in drug-excipient compatibility studies, assay of the tablets and stability studies of Dapivirine and DS003 tablets.
dc.identifier.citationCurrent Pharmaceutical Analysis, 2011; 7(1):21-26
dc.identifier.doi10.2174/157341211794708703
dc.identifier.issn1573-4129
dc.identifier.issn1875-676X
dc.identifier.orcidGarg, S. [0000-0001-7253-2629]
dc.identifier.urihttps://hdl.handle.net/1959.8/122426
dc.language.isoen
dc.publisherBentham Science Publishers
dc.rightsCopyright 2011 Bentham Science Publishers
dc.source.urihttps://doi.org/10.2174/157341211794708703
dc.subjectDapivirine
dc.subjectDS003
dc.subjectHIV
dc.subjectHPLC
dc.subjectmcrobicides
dc.subjectstability indicating method
dc.titleDevelopment and validation of a HPLC method for simultaneous determination of Dapivirine and DS003 in combination Microbicide tablet
dc.typeJournal article
pubs.publication-statusPublished
ror.mmsid9915909241801831

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