A study to determine the pharmacokinetics of gatifloxacin following a single oral dose.
Gatifloxacin is a broad spectrum fluoroquinolone that offers enhanced Gram-positive activity and anaerobic coverage to other fluoroquinolones. The pharmacokinetic parameters (Cmax, AUCo-t, tmax) of this drug have been evaluated to compare the single dose (400mg) bioavailability of gatifloxacin with the reference formulation. High performance liquid chromatography (HPLC) coupled with U-V detector set at 290 nm has been used to determine plasma concentration of 12 human volunteers as per DCGI (Drug Controller General of India) guidelines. The method has been validated over a linear range of 0.25 to 8 microg/ml from plasma. The minimum quantifiable concentration has been set at 0.25 microg/ml (% CV < 10%). The pharmacokinetic parameters are: Cmax = 4.366 +/- 0.44 microg/ml at tmax = 1.83 +/- 0.44 hour, AUCO0-t = 25.26 +/- 2.91 microg hour/ml, AUCo-inf = 33.68 +/- 4.31 microg hour/ml, Kel = 0.094 +/- 0.024/hour and t1/2 = 8.0 +/- 1.92 hour.
Mandal
U
U
Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032.
Musmade
P
P
Ghosh
A
A
Chakraborty
Mita
M
Jayakumar
M
M
Rajan
D Senthil
DS
Chakravarty
M
M
Pal
T K
TK
Chattaraj
T K
TK
Roy
Krishnangshu
K
Banerjee
S N
SN
D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000077734:Gatifloxacin; D006801:Humans
D024841:Fluoroquinolones; D000077734:Gatifloxacin