Simple, sensitive and rapid LC–MS method for the quantitation of indapamide in human plasma—application to pharmacokinetic studies

Abstract A sensitive and specific method using liquid chromatography with electrospray ionization mass spectrometry (LC–ESI–MS) has been developed and validated for the identification and quantification of indapamide in human plasma. A simple liquid–liquid extraction procedure was followed by injection of the extracts on to a C 18 column with gradient elution and detection using a single quadrupole mass spectrometer in selected ion monitoring (SIM) mode. The method was tested using six different plasma batches. Linearity was established for the concentration range 0.5–100.0 ng/ml, with a coefficient of determination ( r ) of 0.9998 and good back-calculated accuracy and precision. The intra- and inter-day precision (RSD%) was lower than 10%, and accuracy ranged from 85 to 115%. The lower limit of quantification was reproducible at 0.2 ng/ml with 0.2 ml plasma. The proposed method enables the unambiguous identification and quantification of indapamide for pre-clinical and clinical studies.