Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ALOGLIPTIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

*Subrata Sarkar and Vipul P. Patel

ABSTRACT

A Simple, precise, rapid, robust and accurate reverse phase-high performance liquid chromatographic method for the determination of Alogliptin in bulk and pharmaceutical dosage form. The chromatographic analysis was performed on a Symmetry C18, 25cm x 4.6mm (i.d.), 5μm, particle size column in isocratic mode, the mobile phase consisted of methanol and 0.01M phosphate buffer (adjusted to pH 3.20 with ortho-phosphoric acid) at a ratio of 65:35 v/v and a flow rate of 1.0 ml/min and UV detector is used. The eluents were monitored at 236nm. The retention time of Alogliptin was found to be 3.447min. The linear ranges were found to be 0-16μg/ml (r =0.999) for Alogliptin. The proposed method is also found to be accurate, precise and robust. The developed method should be applied to the routine quality control of pharmaceutical formulations containing Alogliptin.

Keywords: RP-HPLC, Alogliptin, Method Development, Method Validation, Accuracy.