ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND PIOGLITAZONE HYDROCHLORIDE IN TABLET DOSAGE FORM BY RP-HPLC

A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of Metformin Hcl (MET) and Pioglitazone (PIO) in pure and in pharmaceutical dosage forms. A BDS Hypersil C18column (250x4.6mm, 5μ) was used with a mobile phase containing a mixture of Acetonitrile and Potassium di hydrogen ortho phosphate buffer (pH-3) in the ratio of 50: 50. The flow rate was 1ml/min and effluents were monitored at 238nm and eluted at 2.81min (MET) and 4.57min (PIO). Calibration curve was plotted with a range from 40-240 µg / ml for MET and 12-72 µg / ml for PIO. The assay was validated for the parameters like accuracy, precision, specificity, robustness, ruggedness  and system suitability parameters. The proposed method can be useful in the routine analysis for the determination on metformin and pioglitazone in pharmaceutical dosage forms.

Keywords: MetforminHydrochloride, PioglitazoneHydrochloride, Reverse phase HPLC, Pharmaceutical dosage forms, simultaneous estimation.