Stability indicating gradient liquid chromatographic technique for the simultaneous estimation of rosiglitazone, glimepiride and metformin HCl in pharmaceutical dosage forms

Abstract

A stability indicating high performance liquid chromatographic method has been developed and validated for the anti-diabetic drugs Rosiglitazone, Glimepiride, and Metformin HCl in pharmaceutical dosage forms. Chromatographic separation was achieved on Zorbex SB C-8 (250 X 4.6 mm) 5µ and Hypersil BDS C18 (200 × 4 mm), 5μ column as stationary phase. Mobile phase consisting of 0.023M potassium dihydrogen phosphate and acetonitrile (60:40, v/v) supplied at a flow rate of 1ml/min. Detection was performed using a SPD-20A prominence UV/VIS detector at 230 nm. The retention time of rosiglitazone, glimepiride and metformin hydrochloride was achieved at 2.4 min, 4.5 min and 5.6 min respectively. The method was validated for linearity, precision, accuracy, toughness, specificity, and forced degradation studies and the relative response factor values of rosiglitazone, glimepiride, and metformin determined from linearity study were 0.998 in the combined form. Rosiglitazone, glimepiride, and metformin HCl showed percentage recoveries of 99.73%, 99.81and 100.31%, respectively. The propesd method found to be very effective and stable for the routine analysis of mentioned antidiabetic drugs in pharmaceutical dosage forms.