Abstract
A simple, rapid and precise reverse phase high performance liquid chromatographic (RP- HPLC) method has been developed and validated for simultaneous determination of Metformin hydrochloride and Linagliptin in pure and pharmaceutical dosage forms. The drugs were separated on an analytical column, Phenomex Luna RP-18; reverse phase C 18 column (150×4.6 mm I.D, particle size 5 μm). The mobile phase employed was Phosphate buffer: Methanol: Acetonitrile (65:10:25) in isocratic mode at a flow rate of 1.0 ml/min. 10μl was fixed as injection volume and UV detection was performed at 231 nm. The retention times of Metformin hydrochloride and Linagliptin were 2.2 and 7.8 min respectively. Calibration plots were linear over the concentration ranges 125-750 μg/ml and 0.625-3.75 μg/ml for Metformin hydrochloride and Linagliptin respectively. The method was validated for specificity, accuracy, precision, linearity and robustness. The LOD and LOQ values were calculated mathematically and value for Metformin hydrochloride was 3.08μg/ml and 9.3μg/ml and that of Linagliptin was 2.64μg/ml and 6.9μg/ml respectively. The proposed method was successfully applied for simultaneous analysis of these drugs both in pure and dosage forms.
