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OJVRTM
Online Journal of Veterinary Research©
Volume
25: 185-196, 2021.
Bioequivalence of Meloxicam tablets in volunteers.
Selvadurai Muralidharan,
Janaki Sankarachari Krishnan Nagarajan,
Chandran Sathish Vimal, Anil Dubala and Renjith George
Center for Advanced Drug Research and
Testing, J.S.S.College of Pharmacy, Rocklands, Ooty, Tamilnadu, India.
ABSTRACT
Muralidharan S, Nagarajan
JSK , Vimal CS, Dubala A,
George R, Bioequivalence
of Meloxicam tablets in volunteers, Onl J Vet Res., 25 (3): 185-196, 2021. A chromatographic method for estimation
of Meloxicam tablets in healthy human plasma and its bioequivalence is
described. Twelve healthy human volunteers were administered 15mg in a
randomized, 2 X 2 cross over study. For each dosing session, volunteers
received either the reference formulation or test formulation of Meloxicam
tablets as single dose. Meloxicam was extracted
by protein precipitation and separation by reverse-phase Princeton SPHER C18
column (150 × 4.6mm, 5µ) with mobile
phase of Acetonitrile:Tetrahydrofuran: 0.5% Triethylamine pH 3.5 (30:10:60% (v/v)) at a flow rate of 1 ml/min
detected at 363nm. Results were linear over 75.00-2000.00 ng/ml, regression
coefficient > 0.99, limit of detection was 1.0ng/ml and quantification 3.0ng/ml. Recovery %CV
was <5%. Cmax,
tmax, AUC0-t, keli, half-life, Mean Residence Time and AUC0-∞
results and reference product were bio-equivalent.
Keywords: Meloxicam,
Bioequivalence
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