Green Bio-Analytical Study of Gabapentin in Human Plasma Coupled with Pharmacokinetic and Bioequivalence Assessment Using UPLC-MS/MS

نویسندگان

چکیده

Gabapentin (GAB) is a cyclohexane acetic acid, structurally related to the neurotransmitter gamma-aminobutyric acid (GABA), and considered principal inhibitory in central nervous system (CNS) of mammals. An ultra-performance liquid chromatography–tandem mass spectrophotometry (UPLC-MS/MS) method for assessing pregabalin (PRE) human plasma, was developed validated, via PRE usage as an internal standard. The plasma underwent protein precipitation using methanol, prior analysis. Chromatographic separation completed mobile phase methanol: 0.1% formic solution, (65:35, v/v), at flow rate 0.2 mL/min, with isocratic approach, on Agilent Eclipse plus column (50 × 2.1 mm 1.8 μm), 1.6 min running time. triple quadrupole used analysis, detect ion transitions GAB PER, respectively, m/z 172.1 → 154.1 160.10 142.10. calibration curve, over linear range 0.050–10.0 μg/mL, showed high correlation coefficient, r = 0.9993. limits detection quantitation were 13.37 ng/mL 40.52 ng/mL, based standard deviation slope equation. results intra- inter-day measurement accuracy precision acceptable ranges. extended into assessment oral administrations different doses, one 600 mg/tablet two capsules (each them has 300 mg GAB), volunteers who pharmacokinetics bioequivalent studies. AGREE tool visualize proposed method’s greenness degree, which revealed rating score, supporting accepted profile.

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ژورنال

عنوان ژورنال: Separations

سال: 2023

ISSN: ['2297-8739']

DOI: https://doi.org/10.3390/separations10040234