Development and validation of hplc method for the simultaneous estimation of pioglitazone and alogliptin in bulk and dosage form

A simple, accurate and precise High Performance Liquid Chromatographic (HPLC) method has been developed for simultaneous determination of Pioglitazone and Alogliptin in bulk and dosage form. The method has been validated as per the guidelines of ICH. The separation is achieved on BDS hypersil C18, 250mm × 4.6mm, 5µ (particle size) column with flow rate 1.0 mL per minute in isocratic mode using Buffer pH 3.5: Methanol (70:30) as mobile phase. Column oven temperature is maintained at 25°C and observations are recorded at 271 nm. The linearity range was found to be in the range of 3.75-18.75μg/ml for Pioglitazone and 6.25-31.25 μg/ml for Alogliptin. Correlation co-efficient for calibration curve of Pioglitazone and Alogliptin was found to be 0.9997 and 0.9993 respectively. The method is simple, accurate, reproducible and short and can be used for simultaneous analysis of Pioglitazone and Pioglitazone.