Chromatographic methods and approaches for bioequivalence study, drug screening and enantioseparation of indapamide

Abstract

Indapamide (Indp) and certain other diuretics have been abused in sports, therefore, having sensitive methods for its detection and assay in biological fluids (whole blood, plasma, serum, and urine) is of significant importance. The racemic mixture of Indp is being used as an active pharmaceutical ingredient among other commonly prescribed diuretics. The regulatory authorities and pharmaceutical industries demand analytical methods for successful enantioseparation of such molecules. The paper presents a critical overview of the scientific issues of the application of contemporary techniques involving various chromatographic approaches (with liquid or supercritical fluid as mobile phases) and capillary electrophoresis and method development, for drug screening, assay, bioequivalence studies and enantioseparation of indapamide with their results. It also covers the historical developments that led to significant breakthroughs in research and concise evaluations of research in the area.Different types of chromatographic methods (HPLC, CEC, SFC etc) discussed herein provide an insight and a choice to select a method to (i) screen Indp for drug abuse, (ii) separate, isolate and quantify the enantiomers of Indp and (iii) investigate their pharmacokinetics as markedly different species and not as a total drug. The article evaluates the field's status with a broad base and practical oriented approach so that the underlying principles are easily understood to help chemists and non-specialists gain useful insights into the field outside their specialization and provide experts with summaries of key developments. To the best of authors' knowledge there has been no attempt to review such methods for analysis of Indp and this is the first report of its kind.

Direct Enantiomeric Separation of Indapamide by Thin Layer Chromatography using B- Cyclodextrin as Chiral Selector

“…Literature review reveals that different analytical approaches like UV spectroscopy, RP-HPLC, and HPTLC have been described for the enantioseparation of Indpd, individually and in combination with other drugs. 11 HPLC enantioseparation of Indpd was completed using an ovomucoid protein based Chiral Selector (CS) as stationary phase performed on HPLC instrument from Agilent. An Ultron ES Ovomucoid, column was used for the separation of the two optical isomers.…”

Estudo da oxidação eletroquímica da indapamida para aplicação eletroanalítica

“…O limite de detecção (LOD) foi estimado em 4,00 × 10 -7 mol L -1 (3,30 SDw/yb). A análise do conteúdo do comprimido resultou em uma recuperação de 103% [55], como ilustrado na Figura 23.…”