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dc.contributor.authorMishra, Pooja
dc.contributor.authorAlbiol Chiva, Jaume
dc.contributor.authorBose, Devasish
dc.contributor.authorDurgbanshi, Abhilasha
dc.contributor.authorPeris Vicente, Juan
dc.contributor.authorCarda-Broch, Samuel
dc.contributor.authorEsteve-Romero, Josep
dc.date.accessioned2019-04-01T07:29:24Z
dc.date.available2019-04-01T07:29:24Z
dc.date.issued2018
dc.identifier.citationMISHRA, Pooja, et al. Optimization and Validation of a Chromatographic Method for the Quantification of Isoniazid in Urine of Tuberculosis Patients According to the European Medicines Agency Guideline. Antibiotics, 2018, vol. 7, no 4, p. 107ca_CA
dc.identifier.issn2079-6382
dc.identifier.urihttp://hdl.handle.net/10234/182079
dc.description.abstractIsoniazid is a drug that is widely used against tuberculosis. However, it shows high interpatient variability in metabolism kinetics and clinical effect, which complicates the prescription of the medication and jeopardizes the success of the therapy. Therefore, in a specific patient, the pharmacokinetics of the drug must be elucidated to decide the proper dosage and intake frequency to make the drug suitable for therapeutic drug monitoring. This can be performed by the quantification of the drug in urine as this process is non-invasive and allows the effects of long-time exposure to be inferred. The paper describes the development of a micellar liquid chromatographic method to quantify isoniazid in urine samples. Extraction steps were avoided, making the procedure easy to handle and reducing the waste of toxic organic solvents. Isoniazid was eluted in less than 5 min without interference from other compounds of the urine using a mobile phase containing 0.15 SDS–12.5% 1-propanol (v/v)–Na2HPO4 0.01 M buffered at pH 7, running at 1 mL/min under isocratic mode through a C18 column with the detection wavelength at 265 nm. The method was validated by following the requirements of the Guidelines on Bioanalytical Method Validation issued by the European Medicines Agency (EMA) in terms of selectivity, calibration curve (r2 = 0.9998 in the calibration range (0.03–10.0 μg/mL), limit of detection and quantification (10 and 30 ng/mL respectively), precision (<16.0%), accuracy (−0.9 to +8.5%), carry-over, matrix effect, and robustness. The developed method was applied to quantify isoniazid in urine samples of patients of an Indian hospital with good results. The method was found to be useful for routine analysis to check the amount of isoniazid in these patients and could be used in its therapeutic monitoring.ca_CA
dc.format.extent12 p.ca_CA
dc.format.mimetypeapplication/pdfca_CA
dc.language.isoengca_CA
dc.relation.isPartOfAntibiotics, 2018, vol. 7, no 4ca_CA
dc.rightsAtribución 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectdirect injectionca_CA
dc.subjectdrugca_CA
dc.subjectmicellarca_CA
dc.subjecttuberculosisca_CA
dc.subjecturineca_CA
dc.subjectvalidationca_CA
dc.titleOptimization and Validation of a Chromatographic Method for the Quantification of Isoniazid in Urine of Tuberculosis Patients According to the European Medicines Agency Guidelineca_CA
dc.typeinfo:eu-repo/semantics/articleca_CA
dc.identifier.doihttps://doi.org/10.3390/antibiotics7040107
dc.relation.projectIDConselleria d'Educacio de la Generalitat Valenciana: AICO-2017-063; Universitat Jaume I: UJI-B2018-20ca_CA
dc.rights.accessRightsinfo:eu-repo/semantics/openAccessca_CA
dc.relation.publisherVersionhttps://www.mdpi.com/2079-6382/7/4/107/htmca_CA
dc.contributor.funderThe authors are thankful to Madhya Pradesh Council & Technology (MPCOST), Bhopal, Madhya Pradesh (India)ca_CA
dc.type.versioninfo:eu-repo/semantics/publishedVersionca_CA


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Atribución 4.0 Internacional
Except where otherwise noted, this item's license is described as Atribución 4.0 Internacional