Improved protein deproteinization method for the determination of meloxicam in human plasma and application in pharmacokinetic study.
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.
School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, Minden, Penang, Malaysia.
Kai Bin
KB
Liew
Gabriel Onn Kit
GO
Loh
Yvonne Tze Fung
YT
Tan
Kok Khiang
KK
Peh
D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D001798:Blood Proteins / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018592:Cross-Over Studies; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D016014:Linear Models; D008297:Male; D000077239:Meloxicam; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013810:Therapeutic Equivalency; D013843:Thiazines / Q000009:adverse effects / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D013844:Thiazoles / Q000009:adverse effects / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D055815:Young Adult
D001798:Blood Proteins; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam
HPLC determination; bioequivalence; human plasma; meloxicam; pharmacokinetics