Development and Validation of a RP- HPLC Method for Simultaneous Estimation of Rosiglitazone and Metformin in Bulk and Tablet Dosage Form

Abstract

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been
developed and validated for simultaneous determination of rosiglitazone and metformin in bulk and
tablet dosage form. Chromatographic analysis was performed on a C18 column (250x 4.6 mm, 5µm)
with a mixture of Ammonium dihydrogen Phosphate buffer (pH 4.5): Acetonitrilein in the ratio 65:35
as mobile phase, at a flow rate of 1.0 mL min-1
. UV detection was performed at 230 nm. The method
was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of
rosiglitazone and metformin were 7.190.044 and 5.570.038 min, respectively. Calibration plots
were linear over the concentration ranges 12–32 μg mL-1
and 20–70 μg mL-1
for rosiglitazone and
metformin, respectively. The Limit of detection was 1.100 and 0.712 g mL-1
and the quantification
limit was 3.66 g mL-1
and 2.41 g mL-1
for metformin and rosiglitazone, respectively. The accuracy
of the proposed method was determined by recovery studies and found to be 97.72% to 100.46%.
Commercial tablet formulation was successfully analyzed using the developed method and the
proposed method is applicable to routine analysis of determination of rosiglitazone and metformin in
bulk and tablet dosage form.