In the present study a simple HPLC method was developed and validated
for simultaneous determination of metformin and glibenclamide in newly
designed orodispersible tablets. The separation was attained on ODS C18
column using a mixture of methanol and acetonitrile (70:30 % v/v) as
mobile phase at pH of 3.5 ± 0.05. The retention times recorded for
metformin and glibenclamide were 1.697 and 3.027 min, respectively at a
flow rate of 1.0 mL min-1 and detection wavelength of 232 nm. The
linearity was observed for the concentration range of 0.025-0.5 µg mL-1
with r = 0.996 for metformin and 0.025-0.2 µg mL-1 with r = 0.995 for
glibenclamide. The limits of detection and quantification were 25 ng
mL-1 and 75 ng mL-1 for metformin and 20 ng mL-1 and 60 ng mL-1 for
glibenclamide, respectively. The drug recovery was 99.21 ± 0.78 for
metformin and 98.95 ± 0.44 for glibenclamide. Validations studies
revealed that method was accurate, precise, robust, specific and
sensitive. The method was successfully applied for the pharmacokinetic
study of both drugs after single dose oral administration of newly
designed orodispersible tablets. Various pharmacokinetic parameters,
like Tmax, Cmax, AUC0-t, AUC0-∞, t1/2, and clearance were calculated by
linear trapezoidal method.