K. J. Somaiya

The complexity of the multicomponent dosage forms is that multiple entities and excipients poses a considerable challenge to the analytical chemist during the development of an assay procedure. One of such formulation is of an anti-diabetic medicine comprising metformin hydrochloride (MET), gliclazide (GLZ) and pioglitazine (PIO). Many methods have been reported in the literature for the estimation of MET, GLZ and PIO individually and with other components by chromatographic methods. However, there is no simple reverse phase high performance liquid chromatography (RP-HPLC) method has been reported for the simultaneous estimation of MET, GLZ and PIO. Thus, we have attempted to develop and validate a simple HPLC method for MET, GLZ and PIO. The RP-HPLC method was successfully developed and validated according to ICH guidelines. The proposed method is simple, accurate, precise, and the statistical analysis proved that the method is reproducible and efficient for the simultaneous estimation of MET, GLZ and PIO in tablet dosage form without any interference from the excipients.