Abstract

METHOD DEVELOPMENT AND VALIDATION OF ALOGLIPTIN AND PIOGLITAZONE BY RP- HPLC METHOD IN BULK AND ITS MARKETED DOSAGE FORM

*Maneesha Kandala, R. Mounika, Sana Sultana, Nasimul Hogue, Sujon Ali, S. Prashanthi, Saiful Islam, Sk. Nasim Aktar and Shanawaz Kabir

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Abstract

A simple, rapid, specific and accurate Reverse Phase High Performance Liquid Chromatographic Method have been developed for the validation of Alogliptin & Pioglitazone in bulk as well as in the marketed pharmaceutical dosage form. This separation was performed on a Develosil ODS C18 (4.6mm×250mm, 5μm) column with Acetonitrile: Methanol: 1% Orthophosphoric acid (50:30:20% v/v) as mobile phase at a flow rate of 1.0 ml/ min with UV detection at 242 nm; the constant column temperature was Ambient. The run time under these chromatographic conditions was within 10 min. The retention time of Alogliptin and Pioglitazone was found to be 2.24 and 5.44. The calibration plot was linear over the concentration range of 30-70μg/ ml for Alogliptin and 60-140μg/ ml for Pioglitazone with limit of detection 0.63 & 1.20 for Alogliptin & Pioglitazone and quantification values 1.70 & 3.40 μg/ ml respectively. The mean % assay of marketed formulation was found to be 100.25% and 100.20%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2.The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Alogliptin and Pioglitazone in bulk and marketed pharmaceutical dosage form dosage form.

Keywords: Alogliptine, Pioglitazone, RP-HPLC, Orthophosphoric acid, Methanol, ICH validation guidelines, Osini tablets, Sonicator, Waters HPLC, PDA detector.