ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NATEGLINIDE AND METFORMIN BY RP-HPLC

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Nateglinide and Metformin, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Sunfire C18 (4.6×250mm) 5µ column using a mixture of Water and Acetonitrile (60:40% v/v) as the mobile phase at a flow rate of 0.9ml/min, the detection was carried out at 220nm. The retention time of the Nateglinideand Metformin was 3.0, 3.8±0.02min respectively. The method produce linear responses in the concentration range of 20-100µg/ml of Nateglinideand 50-250µg/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: Nateglinide, Metformin, RP-HPLC and Validation.