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Improved protein deproteinization method for the determination of meloxicam in human plasma and application in pharmacokinetic study.
- Source :
-
Biomedical chromatography : BMC [Biomed Chromatogr] 2014 Dec; Vol. 28 (12), pp. 1782-8. Date of Electronic Publication: 2014 May 02. - Publication Year :
- 2014
-
Abstract
- A simple, rapid, specific and reliable high-performance liquid chromatographic assay of meloxicam in human plasma has been developed using a C18 reversed-phase analytical column. Reversed-phase chromatography was conducted using a mobile phase of 0.02 potassium dihydrogen phosphate (adjusted to pH 2.7 with phosphoric acid)-acetonitrile-triethylamine (35:65:0.05, v/v) with UV detection at 354 nm. The drug in human plasma was deproteinized using a combination of methanol and chloroform. This method is simple, rapid and consistent with a high recovery of meloxicam in human plasma ranging from 93.29 to 111.09%. Regression analysis for the calibration plot for plasma standards obtained for the drug concentrations between (25-4000) ng/mL indicated excellent linearity (r ≥ 0.9997). The proposed method was applied to study the bioequivalence between Mobic (original) and Melocam (generic) products. The study was conducted on using two tablets (4 × 7.5 mg) of each of the commercial product and the reference standard in a two-way open randomized crossover design involving 20 volunteers. Area under the concentration-time curve, peak concentration (C(max)) and time to reach C(max) were 72,868.61 ng h/mL, 2133.93 ng/mL and 4.06 h for Mobic, and 78,352.52 ng h/mL, 2525.18 ng/mL and 3.61 h for Melocam. Two C(max) were discovered in the pharmacokinetic profiles which confirm enterohepatic recirculation.<br /> (Copyright © 2014 John Wiley & Sons, Ltd.)
- Subjects :
- Adult
Blood Pressure drug effects
Blood Proteins isolation & purification
Cross-Over Studies
Heart Rate drug effects
Humans
Linear Models
Male
Meloxicam
Reproducibility of Results
Sensitivity and Specificity
Therapeutic Equivalency
Thiazines adverse effects
Thiazines chemistry
Thiazoles adverse effects
Thiazoles chemistry
Young Adult
Chromatography, High Pressure Liquid methods
Thiazines blood
Thiazines pharmacokinetics
Thiazoles blood
Thiazoles pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 1099-0801
- Volume :
- 28
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Biomedical chromatography : BMC
- Publication Type :
- Academic Journal
- Accession number :
- 24788875
- Full Text :
- https://doi.org/10.1002/bmc.3221