DEVELOPMENT AND VALIDATION OF A STABILITY–INDICATING HPLC-UV METHOD FOR THE DETERMINATION OF PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE IN BULK DRUG AND COMBINED DOSAGE FORM

摘要

A simple, selective and stability indicating high performance liquid chromatographic method was developed and validated for the determination of pioglitazone hydrochloride and metformin hydrochloride in bulk drug and pharmaceutical dosage form. Separation and quantification were achieved on a Kromasil C 18 4.6 x 250 mm, 5 μm 100 ? column. The mobile phase was (50:50) methanol: phosphate buffer, pH 6.5 containing 0.01 M sodium dodecyl sulphate, v/v at a flow rate of 1.5 ml/min. Detection was carried out at a wavelength of 270 nm. The method was validated for precision, accuracy, ruggedness and recovery. Pioglitazone and metformin were exposed to acidic, basic and oxidative stress conditions and the stressed samples were analyzed by the proposed method. Good linear relationship in the concentration range of 50-150% of target concentration with correlation coefficient of 0.995 was obtained. Intra- and inter-day precision were less than 2.5% for both analytes. The stressed sample chromatograms demonstrate the specificity of the proposed method for the determination of target analytes in presence of degradants.