A VALIDATED STABILITY INDICATING RP-HPLC METHOD OF ESTIMATION OF PIOGLITAZONE HCL IN DOSAGE FORMAbstract
This present study aims to develop an accurate, precise, and linear reverse-phase High-Performance Liquid Chromatographic (RP-HPLC) method for the estimation of Pioglitazone HCL in Pharmaceutical dosage form. Method: The chromatographic system employs a reverse-phase Hypersil BDS, C8 250 × 4.6 mm, 5 columns using 0.01M Potassium phosphate buffer and acetonitrile (40:60) as mobile phase, methanol as a diluent in isocratic mode. A flow rate of 1.0 ml/min was optimized with a detection wavelength at 225 nm. The retention time (Rt) was around 4.72 ± 0.2 min. Results: The method was validated with respect to specificity, selectivity, linearity, accuracy, precision, and robustness as per ICH guidelines. The assay method was observed linear in the concentration range of 0.079-0.318 mg/ml with a Correlation coefficient (r2) of 0.9999. The percentage recovery of active pharmaceutical ingredients from tablet dosage form ranged from 99.40-100.40%. Stress conditions of degradation in acidic, alkaline, peroxide, thermal, and UV radiation were studied.