Abstract

DEVELOPMENT OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GLIMEPIRIDE, PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE IN A COMBINED TABLET DOSAGE FORM

Gurpreet Singh Sandhu, Supandeep Singh Hallan and Bhupinder Kaur*

ABSTRACT

In the present work, a rapid, accurate and precise RP-HPLC method for the estimation of Metformin, Pioglitazone and Glimepiride in tablets dosage form [500/15/2mg] by selecting the various chromatographic parameters. A new method was developed using 250 mm x 4.6 mm, reverse phase C18 column, 5 μm (XBridge C18, 250 X 4.6 mm; 5 μ) with mobile phase of 40 volumes of potassium dihydrogen phosphate (Phosphate buffer pH 6.8) and 60 volumes of Methanol as mobile phase and Methanol as diluent run as isocratic elution. Flow rate was 1.0 mL-1 with UV detection at 257 nm and the injection volume was set at 20 μL with 20 minutes of runtime. The method was validated by using various validation parameters like accuracy, precision, linearity, specificity and stability in analytical solution and robustness. All the validation parameters were found to be well within the acceptance criteria. Hence the method can be used for routine estimation of Metformin (as extended release), Pioglitazone and Glimepiride tablets [500/15/2 mg].

Keywords: Metformin HCl, Pioglitazone, Glimepiride, RP-HPLC, Method validation.