Abstract
The aim of this study was to develop and validate f or determination of piroxicam in human plasma by new rapid HPLC method and to compare the relative bioavailability of two branded formulations of piro xicam in healthy Korean volunteers. The analysis running time of piroxicam was just 2 minutes using C 18 column (100 x 4.6 mm, 5 μ m) with variable wavelength detector (at 355 nm). This HPLC method was validated by examining the precision and accuracy for inter- and intra-day analy- sis. A randomized, open-label, single dose, 2-perio d cross- over method was performed in 28 subjects. For analy sis of pharmacokinetic properties, the blood samples we re drawn at 0, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96 and 16 8 hours after dosing. The standard curve was linear (R 2 = 0.9999) over the concentration range of 0.1 - 6 μ g/mL. The rela- tive standard deviation (R.S.D.) and accuracy were 0.2 - 6.1 % and 95.4 - 104.0 %. After single dose of piro xicam 20 mg, the plasma pharmacokinetic parameters, C max , T max , t 1/2 and AUC t were 2.15 ± 0.25 μ g/mL, 2.44 ± 1.15 h, 46.84 ± 8.73 h and 107.42 ± 27.25 μ g·h/mL in the test drug. No significant differences were found based o n analysis of variance, with mean values and 90% CIs of test/reference ratio for these parameters as follow s: C max was 0.9351-1.0377; AUC 0-168 was 0.9510-1.0752. The developed method was successfully applied to bioequivalence study of two branded piroxicam capsu les in 28 healthy Korean. The results of pharmacokineti cs showed two branded piroxicam 20 mg formulations wer e bioequivalent, based on the regulatory definition.
Highlights
Piroxicam [4-hydroxy-2-methyl-N-(2-pyridyl)-2H-1,2benzothiazine-3-carboxamide 1,1-dioxide](Figure. 1) is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs)
The upper layer was transferred to a new tube and a 50 μL of aliquot was injected into the high-performance liquid chromatography (HPLC) system for analysis
Reproducible chromatographic separations were obtained at acetonitrile 5 mM ammonium formate buffer (45:55, v/v)
Summary
Piroxicam [4-hydroxy-2-methyl-N-(2-pyridyl)-2H-1,2benzothiazine-3-carboxamide 1,1-dioxide](Figure. 1) is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). 1) is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). It has been used in the treatment of rheumatoid arthritis, osteoarthritis and other inflammatory disorders in humans (Brogden et al, 1984; Cerretani et al, 1993). Piroxicam is well absorbed following oral administration. Piroxicam binds strongly to plasma protein (>99%) and reached a maximum concentration within three to five hours after oral medication. For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is 20 mg given orally once per day. Because of the long half-life (about 50 hours) of piroxicam, steady-state blood levels are not reached for 7-12 days (Woolf et al., 1989)
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