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A Validated High Performance Liquid Chromatography Method for the Determination of Saxagliptin and Metformin in Bulk, a Stability Indicating Study

Sena Caglar and Ali Rahmi Alp

In this paper a simple, precise and rapid high performance liquid chromatography method with UV detection has been developed for the determination of saxagliptin and metformin in bulk. An Agilent, Zorbax CN (250 × 4.6 mm I.D., 5 μm) column was used with a mobile phase mixture of methanol-50 mM phosphate buffer (pH 2.7) in a gradient elution mode at a flow rate of 1.0 ml min^-1. The analytes were detected at 225 nm and total run time for the method was 7 min. The calibration graphs were linear in the range of 5.00-125.00 μg ml^-1 for saxagliptin and 2.50-62.50 μg ml^-1 for metformin. For stability indicating study, saxagliptin was subjected to acid, neutral and alkali hydrolysis, oxidation and heat stress. The developed method could be used for quality control assay for SAX in tablets and for stability studies as the method separates SAX from its degradation products and tablet excipients.