title: 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.
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 (r(2) ≥ 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.
authors: Research Studies, Rayalaseema University, Kurnool, India.
authors: Vinayender
authors: V
authors: Adireddy
authors: Nageswara Rao
authors: NR
authors: Pilli
authors: Venkata Ramu
authors: VR
authors: Derangula
authors: Shobha Rani
authors: SR
authors: Satla
authors: Chinna Veera Badraiah
authors: CV
authors: Ganguri
authors: Venkateswarlu
authors: V
authors: Ponneri
mesh_terms: D000577:Amides / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D005650:Fumarates / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D006801:Humans; D007194:India; D059625:Liquid-Liquid Extraction; D008297:Male; D019829:Nevirapine; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D000092502:Renin Inhibitors
chemical_list: D000577:Amides; D005650:Fumarates; D019829:Nevirapine; D000092502:Renin Inhibitors; C446481:aliskiren
keywords: LC-MS/MS; aliskiren; human plasma; liquid-liquid extraction; pharmacokinetics