A LC-MS/MS METHOD FOR THE QUANTIFICATION OF DEFLAZACORT METABOLITE IN HUMAN PLASMA: DEVELOPMENT, VALIDATION AND APPLICATION TO A PHARMACOKINETIC STUDY
Abstract
Deflazacort is a methyl-oxazoline derivative of prednisolone used for its anti-inflammatory and immunosuppressive effects. It is an inactive prodrug which is converted rapidly to its active metabolite 21- desacetyl deflazacort. A simple, rapid, sensitive and specific liquid chromatography-tandem mass spectrometry method was developed for the estimation of 21-desacetyl deflazacort in human plasma. Sample preparation involved simple solid phase extraction of 21-desacetyl deflazacort and internal standard. The samples were analyzed using a reversed phase column and detected using positive mode ESI tandem mass spectrometry. The LLOQ was 0.5 ng/mL and the assay was linear over the range of 0.5-100 ng/mL using a sample volume of 250µL. The method was validated for specificity, linearity, precision, accuracy and stability parameters. The method was applied to the analysis of plasma samples after oral administration of 6 mg DFZ tablets of marketed product in healthy adult subjects in a fasting bioavailability study.
Downloads
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).