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Research Journal of Pharmacy and Technology
Year : 2016, Volume : 9, Issue : 7
First page : ( 775) Last page : ( 778)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2016.00148.7

Analytical Method Development and Validation of Alogliptin by RP-HPLC Method

Vinyas M*, Velivela Swapna, Yadav Gopi, Pati Nikunja B, Gupta VRM

Pulla Reddy Institute of Pharmacy, Annaram (V), Jinnaram (M), Medak, Telangana, India-502313

*Corresponding Author E-mail: vinyasmayasa7@gmail.com

Online published on 15 October, 2016.

Abstract

A novel approach was used to develop and validate a rapid, specific, accurate and precise reverse phase high performance liquid chromatographic (HPLC) method for the estimation of Alogliptin phosphate mono-hydrate in pharmaceutical dosage forms. The chromatographic separation was achieved by Shiseido (250 x 4.6 mm, 5μm) column the using ratio of water and methanol as 75: 25(v/v). The flow rate was 1 mL/min and the detection wavelength was 225 nm. The limit of detection (LOD) for Alogliptin phosphate monohydrate was 0.23μg/mland the limit of quantification (LOQ) for Alogliptin phosphate monohydrate was 0.78 μg/ml. This method was validated with respect to linearity, accuracy, precision, specificity and robustness. The method was also found to be stability-indicating.

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Keywords

Alogliptin, Reverse Phase HPLC, Accuracy, Linearity, precision.

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