Abstract

DEVELOPMENT AND VALIDATION RP-HPLC METHOD FOR SAXAGLIPTIN MONOHYDRATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

*Kalyani K. Shete, Udapurkar P.P. and Prof. K. R. Biyani

Abstract

A simple, precise, rapid and reproducible RP-HPLC method was developed and validated for the determination of Saxagliptin monohydrate in Pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a C18 (Grace) column 4.6 x 250 mm i.d., particle size 5μm.). The mobile phase consisted of Acetonitrile: Methanol: Water (pH 3.5 adjusted with orthophosphoric acid) in ratio 40:10:50 (v/v) an gradient elution at a flow rate of 0.7 ml/min at ambient temperature. The detection was carried out at 223 nm using UV-Visible detector. The retention time saxagliptin monohydrate is found to be 3.98 min and the calibration curve was linear in the concentration range of 0-60μg/ ml (r2═ 0.999). The limit of detection and the limit of Quantification were found to be 0.5815, 1.7622 μg/ml respectively. The amount of saxagliptin monohydrate present in the formulation was found to be 99%. The method was validated statistically using the SD, %RSD and values are found to be within the limits and the recovery studies were performed and the percentage recoveries was found to be 105.2,101.5,98.23. So, the proposed method was found to be simple, specific & linear. Hence it can be applied for routine analysis of saxagliptin monohydrate in the pharmaceutical formulations.

Keywords: RP-HPLC, Saxagliptin monohydrate UV detection, Acetonitrile: water: Methanol.