Liquid chromatography-tandem mass spectrometric assay for aliskiren, a novel renin inhibitor in micro-volumes of human plasma: a pharmacokinetic application in healthy South Indian male subjects

• Published in: Biomedical chromatography Vol. 27; no. 8; pp. 1062 - 1069
• Main Authors: Adireddy, Vinayender, Pilli, Nageswara Rao, Derangula, Venkata Ramu, Satla, Shobha Rani, Ganguri, Chinna Veera Badraiah, Ponneri, Venkateswarlu
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.08.2013
• Subjects: aliskiren; Amides - blood; Amides - chemistry; Amides - pharmacokinetics; Chromatography, Liquid - methods; Drug Stability; Fumarates - blood; Fumarates - chemistry; Fumarates - pharmacokinetics; human plasma; Humans; India; LC-MS/MS; Liquid-Liquid Extraction; Male; Nevirapine; pharmacokinetics; Renin - antagonists & inhibitors; Reproducibility of Results; Sensitivity and Specificity; Tandem Mass Spectrometry - methods; India; pharmacokinetics; LC-MS/MS; aliskiren; liquid-liquid extraction; human plasma
• ISSN: 0269-3879; 1099-0801; 1099-0801
• DOI: 10.1002/bmc.2906

ABSTRACT This paper describes a simple, rapid and sensitive liquid chromatography/tandem mass spectrometry assay for the determination of aliskiren in human plasma using nevirapine as an internal standard. Analyte and the internal standard were extracted from 100 μL of human plasma via liquid–liquid extraction using tert‐butyl methyl ether. The chromatographic separation was achieved on a C18 column using a mixture of acetonitrile and 0.1% formic acid (90:10, v/v) as the mobile phase at a flow rate of 0.9 mL/min. The calibration curve obtained was linear (r2 ≥ 0.99) over the concentration range of 0.10–1013 ng/mL. Method validation was performed as per US Food and Drug Administration guidelines and the results met the acceptance criteria. A run time of 2.2 min for each sample made it possible to analyze a greater number of samples in a short time, thus increasing the productivity. The proposed method was found to be applicable to clinical studies. Copyright © 2013 John Wiley & Sons, Ltd.