Abstract

DEVELOPMENT OF NEW SIMULTANEOUS RP-HPLC METHOD FOR THE ESTIMATION OF PIOGLITAZONE AND GLIMEPIRIDE IN THE COMBINED TABLET DOSAGE FORM AND THEN VALIDATION OF THE METHOD

K. Poonam*, Dr. P. Arun, P. Shailendra and D. Neelesh Kumar

Abstract

In the present work, a rapid, accurate and precise RP-HPLC method for the estimation of Pioglitazone and Glimepiride in tablets dosage form [500/15/2mg] by selecting the various chromatographic parameters. A new method was developed using 250mm x 4.6 mm, reverse phase C 18 column, 5μm (XBridge C18, 250 X 4.6 mm; 5μ) 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 257nm and the injection volume was set at 20μL 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 Pioglitazone and Glimepiride tablets [500/15/2 mg].

Keywords: RP-HPLC, Pioglitazone, Glimepiride, Method Development, Analytical Method Validation.