A RP-HPLC method development and validation for simultaneous estimation of metformin HCl and rosiglitazone in bulk and tablet dosage form

摘要

A rapid reverse phase high performance liquid chromatography method has been developed and validated for the determination of Metformin HCl and Rosiglitazone maleate in combined tablet dosage form. Isocratic chromatography was performed on a Symmetry C18 column (150X4.6mm, 5mm, XTerra) with a mobile phase consist of 70:30v/v Methanol : Phosphate buffer (pH 4 with ortho -phosphoric acid) with the flow rate of 0.5ml/min and the detection was monitored out by UV detector at 239 nm. The total run time was less than 10 min. The retention time for Metformin amp; Rosiglitazone maleate was found to be 3.333 and 5.694 min respectively. Various chromatographic parameters including Linearity, precision, accuracy, system suitability, LOD, LOQ and robustness have been evaluated. The proposed method was statistically evaluated and can be applied for routine quality control analysis of Metformin amp; Rosiglitazone maleate in tablets.