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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.
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