Research Article
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 AlpFaculty of Pharmacy, Department of Analytical Chemistry, Istanbul University, Istanbul, Turkey
- *Corresponding Author:
- Sena Caglar
Faculty of Pharmacy
Department of Analytical Chemistry
Istanbul University
34116, Beyazit
Istanbul, Turkey
Tel: +902124400000
Fax: +902124400252
E-mail: senacaglar@yahoo.com, sena@istanbul.edu.tr
Received date: March 24, 2014; Accepted date: April 18, 2014; Published date: April 22, 2014
Citation: Caglar S, Alp AR (2014) A Validated High Performance Liquid Chromatography Method for the Determination of Saxagliptin and Metformin in Bulk, a Stability Indicating Study. J Anal Bioanal Tech S12:010 doi: 10.4172/2155-9872.S12-010
Copyright: © 2014 Caglar S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
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.
