Original Articles
Regina Andayani*, Fifi Pitasar
Abstract
Simultaneous determination of two antidiabetic drugs, metformin HCl and glibenclamide in pharmaceutical tablet formulations were investigated. A simple, rapid, precise, and accurate thin layer chromatography-densitometry (TLC-Densitometry) had been developed for the determination of mixed metformin HCl and glibenclamide in tablet dosage forms. Normal phase thin layer chromatography plate (silica gel 60 F254) was used as stationary phase and methanol: water: glacial acetic acid (6:4:0.25) as mobile phase. This system gave a good resolution for metformin HCL (Rf value of 0.52) and glibenclamide (Rf value of 0.78). Determination was done by densitometry in the absorbance mode at 237 nm and 300 nm for metformin HCl and glibenclamide respectively. The method was validated for linearity, precision and accuracy. The linear regression data for the calibration plot showed a good relationship with r = 0.999 and 0.996 for metformin HCl and glibenclamide, respectively. Precision of the method were between 0.56-2.02% for metformin HCl and 0.08-1.30% for glibenclamide. Accuracy of the method was found to be 88.43-104.54% for metformin HCl and 97.22-102.88% for glibenclamide. According to the results, this method was in accordance with good validation requirements.