Development and Validation of High-Performance Thin- Layer Chromatography Method for the Simultaneous Densitometric Determination of Metformin and Rosiglitazone in Tablets

This paper describes validated High-Performance thin-layer chromatography (HPTLC) method for the simultaneous determination of metformin (MET) and rosiglitazone (ROS) in combined tablet dosage forms. The HPTLC separation was carried out on aluminum backed silica gel 60F254 layers using methanoltetrahydrofuran- ammonia, 8:3:1.5 (v/v/v), as the mobile phase. Quantification was achieved with UV detection at 262nm. The developed analytical method was validated according to International Conference on Harmonization guidelines in terms of parameters like accuracy, precision, linearity, and specificity. Good linearity was observed in the concentrations ranging from 0.12 to 0.48 and 15 to 60 μg/band for ROS and MET, respectively. The recovery study results ranged from 98 to 103% for MET and ROS, showing the accuracy of the method. The method was successfully applied for the analysis of the drugs in laboratory prepared mixtures and commercial tablets. The developed method is simple, precise, and sensitive, and applicable for simultaneous determination of MET and ROS in pure powder and tablets.