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Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Linagliptin and Metformin, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6×250mm) 5µ column using a mixture of Water and Acetonitrile (50:50) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 244nm. The retention time of the Linagliptin and Metformin was 2.0, 4.0±0.02min respectively. The method produce linear responses in the concentration range of 20-100µg/ml of Linagliptin and 40-200µg/ml of Metformin. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords

Linagliptin Metformin RP-HPLC Validation

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