Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 54, Issue 5, Pages 1163-1172Publisher
ELSEVIER
DOI: 10.1016/j.jpba.2010.12.005
Keywords
Strong immiscible diluents; Large volume injection; Indapamide; Whole blood; LC-ESI/MS2
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Large volume injection of samples in strong diluents immiscible with the mobile phases used in reversed phase liquid chromatography (RPLC) has been recently introduced in practice. In the present work, the potential of the technique has been evaluated for bioanalytical applications. The process consists of the liquid-liquid extraction of indapamide from whole blood into 1-octanol, followed by the direct injection from the organic layer into the LC. Detection was made through negative electrospray ionization (ESI) and tandem mass spectrometry (MS2). The method was developed, validated, and successfully applied to a large number of samples in two bioequivalence studies designed for indapamide 1.5 mg sustained release and 2.5 mg immediate release pharmaceutical formulations. The performance of the analytical method is discussed based on data resulting from the validation procedure and the completion of the bioequivalence studies. (C) 2010 Elsevier B.V. All rights reserved.
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