Development and Validation of RP-HPLC method for the simultaneous estimation of Miglitol and Metformin Hcl in Pharmaceutical formulations

Abstract

A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC)
method has been developed and subsequently validated for the simultaneous estimation of Miglitol (MG) and
Metformin Hydrochloride (MT) and in pure and tablet formulation. The proposed method is based on the
separation of the two drugs in reversed-phase mode using zorabaxC18 column (250×4.6 mm I.D., 5 μm particle
size). The optimum mobile phase consists of Phosphate buffer of (pH 4.0): Methanol in the ratio of 80:20 v/v
was selected as a mobile phase, flow rate is 1.0 ml/min and the αmax of UV detection was set at 251 nm. The
retention times were observed at 3.045 and 4.460 min for Miglitol and Metformin Hydrochloride respectively.
The method was validated according to ICH guidelines. The method could be accurate and reproducible.
Linearity was obtained in the concentration range of 50-150% for Miglitol and 50-150% Metformin
Hydrochloride. Mean percent recovery of samples at each level for both drugs were found in the range of 100%.
The proposed method could be successfully applied in the quality control of bulk and pharmaceutical dosage
forms.