Application of a validated ultra performance liquid chromatography–tandem mass spectrometry method for the quantification of darunavir in human plasma for a bioequivalence study in Indian subjects

• Published in: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 879; no. 24; pp. 2443 - 2453
• Main Authors: Gupta, Ajay, Singhal, Puran, Shrivastav, Pranav S., Sanyal, Mallika
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 15.08.2011; Elsevier
• Subjects: Analysis; Analytical, structural and metabolic biochemistry; Bioequivalence study; Biological and medical sciences; Chromatography; Chromatography, High Pressure Liquid - methods; Darunavir; Fundamental and applied biological sciences. Psychology; General pharmacology; Human; Human plasma; Humans; Incurred sample reanalysis; India; Indian; Linearity; liquid chromatography; liquid-liquid extraction; Liquids; Mass spectrometry; Medical sciences; monitoring; particle size; pharmacokinetics; Pharmacology. Drug treatments; proteinase inhibitors; Recovery; Reproducibility; spectrometers; Sulfonamides - blood; Sulfonamides - pharmacokinetics; tandem mass spectrometry; Tandem Mass Spectrometry - methods; Therapeutic Equivalency; UPLC–MS/MS; Asia; India; Bioequivalence study; Human plasma; Darunavir; UPLC–MS/MS; Incurred sample reanalysis; Human; Validation; Biological fluid; Antiretroviral agent; Sulfonamide; Bioequivalence; Non peptide compound; Blood plasma; Antiviral; UPLC-MS/MS; Pharmacokinetics; Protease inhibitor; Quantitative analysis

A simple, precise and rapid ultra performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) method has been developed and validated for the quantification of darunavir, a protease inhibitor, using darunavir-d9 as internal standard (IS). The method involved liquid–liquid extraction of d...