A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ALOGLIPTINE AND PIOGLITAZONE IN BULK AND PHARMACEUTICAL FORMULATIONS

B. Neelima, P. Ravi Kumar, V. Hima Bindu, Y. Rajendra Prasad

The proposed study, a new stability- indicating RP-HPLC method has been developed for estimation of Alogliptin and Pioglitazone in bulk and pharmaceutical dosage form. The present method was a sensitive, precise, and accurate RP-HPLC method for the analysis of Alogliptin and Pioglitazone. To optimize the mobile phase, various combinations of buffer and organic solvents were used on Hypersil BDS C18 column. Then the mobile phase containing a mixture of Phosphate Buffer: Acetonitrile in the ratio of 45:55 % v/v was selected at a flow rate of 1.0 ml/min for developing the method and the peaks with good shape and resolution were found resulting in short retention time, baseline stability and minimum noise. The retention times of Alogliptine and Pioglitazone were found to be 3.42 and 5.24 min respectively. Quantitative linearity was obeyed in the concentration range of 31-187 and 75-450 µg/mL of Alogliptin and Pioglitazone respectively. The limit of detection and limit of quantitation were found to be 0.399 µg/mL and 1.21µg/mL (ALO); 0.516 µg/ mL and 1.565 µg/mL (PIO) respectively, which indicates the sensitivity of the method. The high percentage recovery indicates that the proposed method is highly accurate. No interfering peaks were found in the chromatogram indicating that excipients used in tablet formulations did not interfere with the estimation of the drugs by the proposed HPLC method.