Simultaneous determination of metformin and glibenclamide by RP-HPLC in orodispersible tablets and their pharmacokinetic evaluation
Abstract
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.
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