Development and Validation of a Simple RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Rosiglitazone in Pharmaceutical Dosage Forms

Abstract

The objective of this study was to develop a simple, efficient, precise and accurate reversed phase
HPLC (RP-HPLC) method for simultaneous determination of metformin in combination with rosiglitazone in newly
formulated tablets. The combination of these drugs are commonly used and prescribed as anti-diabetic drugs in
Bangladesh. The method has been developed by using the mobile phase comprising of sodium dihydrogen phosphate
(NaH2PO4) buffer (pH 3.5) and acetonitrile (60:40, v/v) at a flow rate of 0.7 ml/min over C18 bonded silica column
(ODS) (250 x 4.6 mm, 5 μ) at ambient temperature. The effluents were monitored at 230 nm and retention times were
found to be 3.35 min and 11.95 min for metformin and rosiglitazone, respectively. Calibration curves were
determined with a range from 0.03125 to 0.50 μmole/ml of standards and the regression coefficients (r2) were found
as 0.999 for metformin and 1.0 for rosiglitazone. The assay was validated for the accuracy, precision etc. according to
ICH, USP and FDA guidelines. The proposed method can be useful in routine analysis for quantitative determination
of metformin hydrochloride and rosiglitazone in pharmaceutical dosage forms.