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

Abstract

The aim of this study was to develop and validate for determination of piroxicam in human plasma by new rapid HPLC method and to compare the relative bioavailability of two branded formulations of piroxicam in healthy Korean volunteers. The analysis running time of piroxicam was just 2 minutes using C 18 column (100 x 4.6 mm, 5 µm) with variable wavelength detector (at 355 nm). This HPLC method was validated by examining the precision and accuracy for inter-and intra-day analysis. A randomized, open-label, single dose, 2-period crossover method was performed in 28 subjects. For analysis of pharmacokinetic properties, the blood samples were drawn at 0, 1, 2, 3, 4, 5, 6, 12, 24, 48, 96 and 168 hours after dosing. The standard curve was linear (R 2 = 0.9999) over the concentration range of 0.1-6 µg/mL. The relative standard deviation (R.S.D.) and accuracy were 0.2-6.1 % and 95.4-104.0 %. After single dose of piroxicam 20 mg, the plasma pharmacokinetic parameters, C max , T max , t 1/2 and AUC t were 2.15 ± 0.25 µg/mL, 2.44 ± 1.15 h, 46.84 ± 8.73 h and 107.42 ± 27.25 µg•h/mL in the test drug. No significant differences were found based on analysis of variance, with mean values and 90% CIs of test/reference ratio for these parameters as follows: 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 capsules in 28 healthy Korean. The results of pharmacokinetics showed two branded piroxicam 20 mg formulations were bioequivalent, based on the regulatory definition.

Computer-aided design of liposomal drugs: In silico prediction and experimental validation of drug candidates for liposomal remote loading

“…The column used for all three drugs tested was Waters, XBridge C18 5µm 4.6×150 column. The chromatographic conditions were based on published methods [23–25]. Total (free plus liposomal) drug concentration was determined by HPLC assay of the liposomal dispersion diluted with methanol.…”

Piroxicam immediate release formulations: A fasting randomized open‐label crossover bioequivalence study in healthy volunteers

“…8,9 Good separation of piroxicam and IS was obtained with short run times (1.9 and 1.3 minutes for piroxicam and IS, respectively). Calibration curves (n ¼ 10) were found to be linear over the entire concentration range of piroxicam (0.025-5 mg/ mL), with a correlation coefficient R 2 > 0.999 throughout the course of the assay.…”

“…Within-and between-day precision and accuracy of the 3 QCs and LLOQ of piroxicam in human plasma were listed in Table 1. [5][6][7][8][9] Pharmacokinetics and Bioequivalence Evaluation Precision was expressed as the percentage of the CV.…”

“…1,2 Due to the long half life ($50 hours) of piroxicam, steady-state blood levels are reached within 7-12 days. [5][6][7][8][9] However, a new simple technique, compared with the existing methods, was developed and successfully validated according to the guidelines of Food and Drug Administration (FDA). 4 The metabolism of piroxicam is predominantly mediated via cytochrome P450 2C9.…”

Development and Validation of Analytical Methods for Pharmaceuticals

“…The choice of analytical methodology is based on many considerations, such as: chemical properties of the analyte and its concentration [2], sample matrix, the speed and cost of the analysis, type of measurements i.e., quantitative or qualitative and the number of samples. A qualitative method yields information of the chemical identity of the species in the sample.…”