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

Author(s): Chen WD, Liang Y, Zhang H, Li H, Xiong Y, Wang GJ, Xie L

Affiliation(s): Key Lab of Drug Metabolism & Pharmacokinetics E04#, China Pharmaceutical University, 1 Shennong Road, Nanjing 210038, and The hospital of the 17(th) metallurgical construction company, Maanshan 243000, China.

Publication date & source: 2006-09-14, J Chromatogr B Analyt Technol Biomed Life Sci., 842(1):58-63. Epub 2006 Jul 14.

Publication type: Randomized Controlled Trial; Validation Studies

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 C18 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.