The aim of this present work was to develop and validate a simple, rapid, accurate RP-HPLC Stability Indicating Assay Method for the simultaneous estimation of Metformin Hydrochloride (MET) and Gliclazide (GLI) pharmaceutical dosage form. The chromatographic separation was carried out in an isocratic mode using an Kromasil C18 column (250 mm × 4.6 mm, 5 μm particle size) with a mobile phase of mixed phosphate buffer pH 3:acetonitrile(45:55% v/v) of injection volume 20 μL and the eluents were monitored at 230 nm. The retention times of MET and GLI were 2.4 and 9.7 mins respectively. The method was found to be linear over the concentration range of 125-375 μg/mL for MET and 20-60 μg/mL for GLI with a correlation coefficient of 0.999. The proposed RP-HPLC method was validated according to ICH guidelines and was successfully employed for routine quality control analysis in combined dosage forms.
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