生物等效性和生物利用度杂志

抽象的

Pharmacokinetic Profiles of Two Branded Formulations of Piroxicam 20mg in Healthy Korean Volunteers by a Rapid Isocratic HPLC Method

Hyun Ho Song, Kwang Sik Choi, Chan-Wha Kim and Young Ee Kwon

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.