The aim of this study was to develop and validate a selective and
sensitive ion-pairing HPLC–UV method for the determination of metformin in
human urine using a conventional reversed-phase column. Urine provides a
non-invasive sample collection method, and the determination of drug levels in
urine is comparatively less complex than in plasma and other body fluids. The
bioanalytical method was carried out using an RP-C18 column (250×4.0 mm; 5µm). A
mobile phase consisting of acetonitrile and 10 mM sodium phosphate buffer
(pH=6.0, 30:70 v/v) and sodium dodecyl sulfate (0.3%) was pumped at an
isocratic flow rate of 1.00 mL/minute and quantification was achieved at 236 nm
using a UV/VIS DAD. The applicability of the method was confirmed in a study of
urinary excretion of metformin by healthy volunteers after oral administration
of commercially available tablets. The calibration curves were linear (r2
>0.999) in the concentration ranges of 62.5–2000 µg/mL
for metformin in urine. LOD and LOQ were found to be 12 µg/mL
and 35 µg/mL, respectively. The method was found to be rapid, precise, and
accurate for quantification of metformin in human urine. The study illustrates
the characteristics of drug excretion at a single dose of metformin in healthy
subjects. Drug excretion is in the trend of increase and accumulation, but the
discharge rate is not constant, the accumulative urine drug method can
indirectly reflect the metabolic process of the drug in the body. This method
was successfully applied to a pharmacokinetic study of humans through oral
administration.
Author(s) Details
Eva
Troja
Profarma SH.A. Pharmaceutical Industry, Tirana, Albania.
Leonard
Deda
Department of Biomedical Sciences, Faculty of Medicine, University
of Medicine, Tirana, Albania.
Please see the book here:- https://doi.org/10.9734/bpi/mmrnp/v2/1340
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